Compliance monitoring for inhalers

ABSTRACT

Devices and methods are disclosed for monitoring a patient&#39;s compliance with an inhaler treatment regimen. The device may monitor an inhaler&#39;s motion to determine whether the motion is characteristic of typical inhaler use. Additionally, the device may monitor a temperature of the inhaler or in proximity to the mouthpiece to determine whether a patient has used the inhaler. The devices and methods may incorporate a smart phone application that provides notifications and alerts to aid in compliance with the medication regimen.

PRIORITY AND INCORPORATION

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Inparticular, the present application is a continuation of U.S. patentapplication Ser. No. 14/054,638, filed Oct. 15, 2013, titled “COMPLIANCEMONITORING FOR ASTHMA INHALERS,” which claims the benefit under 35U.S.C. §119(e) of both U.S. Provisional Patent Application No.61/836,580, filed Jun. 18, 2013, and also of U.S. Provisional PatentApplication No. 61/883,155, filed Sep. 26, 2013, both titled “COMPLIANCEMONITORING FOR ASTHMA INHALERS.” The entire disclosure of each of theabove items (including each appendix of the second listed provisionalapplication) is hereby made part of this specification as if set forthfully herein and incorporated by reference for all purposes, for allthat each contains.

BACKGROUND

Asthma is a chronic respiratory condition that causes a patient'sairways to narrow, making it difficult to breath. Additionally, asthmamay cause wheezing, chest tightening, shortness of breath and coughing.Asthma is generally caused by an oversensitivity to inhaled substancesthat causes the smooth muscle lining in the bronchial airways toconstrict and tighten. The airways may also swell and secrete mucous,further constricting airflow. During Asthma attacks, a patient's airwaysmay narrow to the point where the condition may be life threatening.Some treatments for Asthma are administered periodically through themouth of a patient. Various devices can be used to administer thesetreatments.

SUMMARY

Improving compliance with treatment regimes that call for periodicadministration may have a multitude of benefits including reduced healthcare costs, reduced health insurance premiums for patients, and improvedpatient quality of life. Examples of such regimes include thoseinvolving inhalers of various types that introduce therapeutic agentsinto the respiratory system. Thus, to take Asthma treatments as anexample, a need exists for systems and methods to increase thecompliance of patient's periodic (e.g., daily) preventive asthmatreatments to reduce costs for preventable hospitalizations due toasthma attacks. Additionally, a need exists for systems and methods thatare appropriately adaptable to several types of inhalers. However, thevariety of inhaler types and operation makes it difficult to develop astandardized monitor for monitoring compliance. Aspects of the presentdisclosure address some of these needs.

Example embodiments described herein have several features, no singleone of which is indispensable or solely responsible for their desirableattributes. Without limiting the scope of the claims, some of theadvantageous features will now be summarized.

For example, a system for assisting a patient in compliance with anasthma medication dosage regimen can be provided. The system cancomprise: a housing configured to be removably connectable to an asthmainhaler configured to enclose asthma medication; a memory incommunication with the controller; a battery in electrical communicationwith the controller and the memory; an alert indicator; a communicationinterface for sending and receiving data that is in electricalcommunication with the controller and the memory; a motion sensor inelectrical communication with the controller that detects at least aposition and a motion of the housing with respect to gravity, the motionsensor physically coupled to the asthma inhaler such that it can detectsignature motions of the inhaler and the enclosed asthma medication, thesignature motions indicative of preparation by a user for administrationof a dose of the asthma medication; and a temperature sensor inelectrical communication with the controller, the temperature sensorconfigured to detect confirming temperatures on or near the asthmainhaler within a time window of any signature motions, the confirmingtemperatures indicative that the user followed the proper procedure foradministering a dose of the asthma medication. The system can furthercomprise a controller configured to: process data output from the motionsensor to determine signature motions; process data output from thetemperature sensor to determine confirming temperatures; and evaluatethe timing of any signature motions and confirming temperatures todetermine whether a use of an asthma inhaler by a patient has occurredto deliver a dose of the asthma medication.

Moreover, a system such as the one summarized above can assist a patientin compliance with an asthma medication dosage regimen by processingdata output from the motion sensor, which can include one or more of thefollowing: analyzing frequency of the data (e.g., by implementing aband-pass filter that passes frequencies at least in the range of 3-7Hz., for example); and/or processing of acceleration data (which caninclude, e.g., determining whether the acceleration data reaches acertain threshold magnitude). One example of the signature motiondiscussed above can be a shaking motion. The temperature sensormentioned in the above paragraph can be, for example, an infra-redtemperature sensor positioned on the housing and/or otherwise configuredto detect proximity and/or temperature of a patient's oral cavity thatmay indicate actual use of an asthma inhaler. The temperature sensormentioned above can be, for example, positioned and/or configured tosense a temperature of a pressurized cartridge of an inhaler.

A monitor for detecting usage of an asthma inhaler can be provided. Themonitor can comprise: a housing; a controller; a wireless communicationinterface in electronic communication with the controller and connectedto the housing; and a memory and a battery in electrical communicationwith the controller and contained within the housing. The monitor canfurther comprise a motion sensor in electrical communication with thecontroller that outputs data indicative of an acceleration of thehousing, and the motion sensor can be physically coupled to the asthmainhaler such that it can detect signature motions of the inhaler and theenclosed asthma medication. The signature motions can indicatepreparation by a user for administration of a dose of the asthmamedication. The monitor can further comprise a temperature sensor inelectrical communication with the controller, and the temperature sensorcan be configured to detect temperatures on or near the asthma inhalerwithin a time window of any signature motions, the temperaturesindicative that the user inhaled the medication. The monitor can furthercomprise a controller configured to: process data output from the motionsensor to identify signature motions; process data output from thetemperature sensor to identify confirming temperatures; and evaluate thetiming of any signature motions and confirming temperatures to determinewhether a use of an asthma inhaler has occurred.

Moreover, the monitor described in the previous paragraph can evaluatethe timing of any signature motions and confirming temperatures by doingone or more of the following: determining whether the temperature dataindicative of use occurred later in time than the motion data indicativeof use; identifying a decrease in temperature of a pressurized cartridgeof the asthma inhaler; identifying a temperature increase in proximityto a mouthpiece connected to the housing of the inhaler; and/oridentifying a temperature increases by an amount indicative of apatient's mouth being in proximity to a mouthpiece connected to aninhaler housing. The controller of the monitor described above can beconfigured to process data output from the motion sensor to identifysignature motions that result from a lever being actuated on a DPIinhaler.

A method of processing data output from a series of sensors connected toan asthma inhaler can be provided, thereby determining whether theasthma inhaler has been used. The method can include one or more of thefollowing steps: detecting data relating to signature motions of thesensors, the signature motions indicative of preparation by a user foradministration of a dose of the asthma medication; detecting atemperature on or near the asthma inhaler within a time window of anysignature motions, the temperatures indicative that the user inhaled themedication; processing the signature motion data to determine whether itis indicative of use of an asthma inhaler; processing the temperaturedata to determine whether it is indicative of use of an asthma inhaler;and evaluating the timing of the signature motion data relative to thetemperature data to determining whether an asthma inhaler has been used.

Moreover, a method such as that described in the previous paragraph canfurther include associating a date, time, and location with a use afterthe evaluating step has confirmed that a use of an asthma inhaler hasoccurred. In the method(s) described above, detecting data relating tothe motion of the sensors can further include detecting an acceleration.In the method(s) described above, processing the temperature data caninclude determining whether a temperature of an inhaler cartridge hasdecreased. In the method(s) described above, processing the motion datacan include determining whether a frequency of the acceleration reachesa threshold magnitude.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings and the associated descriptions are provided toillustrate embodiments of the present disclosure and do not limit thescope of the claims. Aspects and many of the attendant advantages ofthis disclosure will become more readily appreciated as the same becomebetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is an overview of an asthma compliance monitoring system.

FIG. 2A is a perspective view of a metered dose inhaler (MDI).

FIG. 2B is a perspective view of a dry powdered inhaler (DPI).

FIG. 2C is a perspective view of a nebulizer inhalation system.

FIG. 2D is a perspective view of piezoelectric nebulizer inhaler.

FIG. 2E is a perspective view of an example nebulizer inhaler systemthat uses an internal piston compressor.

FIG. 3A is a perspective view of a monitor housing configured as a capand attached to a metered dose inhaler.

FIG. 3B is a perspective view of a monitor housing configured as a ringand attached to a metered dose inhaler.

FIG. 3C is a perspective view of a monitor housing connected to ametered dose inhaler

FIG. 3D is a perspective view of a monitor housing connected near themouthpiece of a metered dose inhaler.

FIG. 3E is a side view of a monitor in the shape of a clip.

FIG. 3F is a perspective view of a monitor in the shape of a clip.

FIG. 3G illustrates a monitor in the shape of a clip attached to ametered dose inhaler.

FIG. 4A is a perspective view of a monitor housing connected to a topportion of a dry powdered inhaler.

FIG. 4B is a perspective view of a monitor housing connected to a sideportion of a dry powdered inhaler.

FIG. 4C is a perspective view of a monitor in the form of a clip for aDPI inhaler.

FIG. 4D is a perspective view of a monitor in the form of a clip for aDPI inhaler that has been attached to an inhaler.

FIG. 4E is a side view of a monitor in the form of a clip for a DPIinhaler that has been attached to an inhaler.

FIG. 4F is a perspective view of a monitor in the form of a cover for aDPI inhaler.

FIG. 4G is a perspective view of a monitor in the form of a cover for aDPI inhaler that has been attached to an inhaler.

FIG. 4H is a plan view of a monitor in the form of a cover for a DPIinhaler that has been attached to an inhaler, with angles indicatedschematically.

FIG. 4I is a section view of two portions of a cover for a DPI inhaler.

FIG. 4J is a perspective view of a low-profile sensor mounted on theback of a DPI inhaler.

FIG. 5 is a perspective view of a monitor housing connected near amouthpiece of a nebulizer.

FIG. 6 is a perspective view of a monitor housing connected near amouthpiece of a piezoelectric nebulizer.

FIG. 7 is an overview of the components of a monitor.

FIG. 8 is an overview of the components of a system including a monitorintegrated with an application installed on a mobile device.

FIG. 9 illustrates an example system architecture diagram for sensors.

FIG. 10 illustrates an example of how a modular device may be able tointerface with different types of inhalers and may be able todistinguish between them.

FIG. 11 illustrates a combined system overview with device hardware,software and a web portal.

FIG. 12 is a sequence of steps for monitoring usage of an inhaler.

FIG. 13 is a flow chart representing the processing of inhaler usagedata.

FIG. 14 is an overview of the inhaler compliance system.

FIG. 15 is an overview of the refill monitoring and ordering system.

FIG. 16 is a flow chart representing the sequence of steps for orderinga refill.

FIG. 17 illustrates an overview of a system utilizing a neural network.

FIG. 18 illustrates a perspective view of a MDI inhaler and a universalmonitor.

FIG. 19 illustrates a perspective view of a DPI inhaler and a universalmonitor.

FIG. 20 illustrates schematically how one or more sensors can confirmthat one or more criteria have been completed.

FIG. 21A shows accelerometer data taken when an accelerometer is shakenin the way that an inhaler would be shaken before use.

FIG. 21B shows data from a longer period of time that includes the timedepicted in FIG. 21A.

FIG. 21C shows data gathered during a short sprint of only a few steps,with the accelerometer being held in a pocket.

FIG. 21D shows data gathered during a short sprint of only a few steps,with the accelerometer being held in a hand.

FIG. 21E shows acceleration data for walking while holding theaccelerometer in a pocket.

FIG. 21F shows data for tossing the accelerometer into the air andcatching it repeatedly.

FIGS. 22A and 22B include data from picking up a DPI and moving itlaterally toward the mouth of a user.

FIG. 22C shows data from a user bringing the device up to their mouthand moving it away multiple times.

FIG. 22D shows data recorded while picking up an inhaler, moving ittoward the mouth, breathing, moving it away and then putting it down.

FIG. 23 shows data from a gyroscope sensor to validate use in accordancewith a rotating embodiment such as those of FIG. 4F-FIG. 4I.

FIGS. 24A-24B show temperature data from ambient air and a human cheek.

FIGS. 24C-24D show temperature data from four human exhale-inhaleevents.

FIG. 24E-24F show temperature data using a clear plastic cover.

FIG. 24G-24H show data taken with another plastic covering.

FIG. 24I-24J show data from further testing.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsappended hereto is not limited by any of the particular embodimentsdescribed below. For example, in any method or process disclosed herein,the acts or operations of the method or process may be performed in anysuitable sequence and are not necessarily limited to any particulardisclosed sequence. Various operations may be described as multiplediscrete operations in turn, in a manner that may be helpful inunderstanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents. For purposes of comparing various embodiments, certainaspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, various embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheraspects or advantages as may also be taught or suggested herein.

This disclosure relates to systems and methods that help monitormovement and temperature, for example. Sensors (including movement andtemperature s) can be used to assist in compliance with medicalinstructions. To take one example, periodic dosing can be improved bysensors that track movements and temperatures associated withadministration of therapeutic agents. Medications that call for use ofan inhaler can be particularly well suited for a system that assists intracking periodic administration, because they are often administeredafter a vigorous shaking motion is used to mix the therapeuticingredients. This motion can be detected with motion sensors. Moreover,they are often administered using an inhaler that is placed in closeproximity to or within an oral cavity. Because this is a warmenvironment, temperature sensors can be advantageously used to trackwhen doses are administered. The change in pressure involved as somepressurized inhaler containers are discharged can also lead totemperature changes that can be tracked or sensed with temperaturesensors. Several other physical characteristics of such dosing systemsand their interactions with human subjects are discussed further herein.Because asthma treatments are commonly provided through inhalers andoften call for regular periodic dosing, this disclosure refers toasthma. However, these examples are not limiting but merely serve toprovide context and one example use for the technology described herein.

For example, other treatment regimes that require certain motions andinteraction with the human body may allow for implementation of similardevices and methods. Diabetes requires periodic administration ofdosages of insulin, and/or periodic measuring of blood glucose. Thevarious motions associated with preparing the insulin dosage or bloodtesting kit may be analyzed along with the temperature changes thataccompanying bringing an injection devices or blood tester in closeproximity to the body. Accordingly, these devices may apply to a widerange of systems and methods and inhaler may be replaced with needles,syringes, testers, and other devices that may come into proximity withthe human body.

The precise mechanism and triggers that cause asthma are unknown andwidely variable among patients. Certain environmental, temporal andgenetic factors may increase or change a patient's susceptibility to anattack at a given time. For example, certain patients may be sensitiveto different types of inhaled irritants, or may be more susceptibleduring exercise. Therefore, predicting asthmatic reactions in patientsis difficult, and patients generally rely on unscientific experience todetermine their specific triggers.

In the United States alone, over 25 million people suffer from asthma, 7million of which are children. Asthma has no cure, but may be managedwith inhaled medications. Some patients may even eliminate most symptomsof asthma with regular usage of medication. Generally, asthmamedications may be broken down into two categories: daily preventivetreatments and rescue medications. Rescue medications are generallybronchodilators that quickly relax the smooth muscle in the bronchiolesin order to dilate the airways and improve ease of breathing during anasthma attack.

Daily preventive treatments typically include anti-inflammatory drugsthat reduce the swelling and mucous production in the airways andaccordingly reduce a patient's susceptibility to triggers. Preventativeanti-inflammatories are effective at controlling and even preventingasthma symptoms.

However, preventive treatments are only effective if they are takenconsistently at the prescribed times. According to a study by the JohnsHopkins and Allergy center, compliance rates are commonly reported to bein the range of 30%-70% among children and adult patients. Generally,asthma compliance is difficult to maintain because the medications maybe required three times daily, and remission of symptoms due tonon-compliance does not occur for several days. Thus, the delayedfeedback in remission removes critical reinforcement to the importanceof taking the medication consistently. Also, many patients may have asmany as three different types of medication, making the differentinhalers difficult to account for. Accordingly, Asthma treatmentcompliance is difficult to maintain among asthma patients, especially inthe case of adolescents and children. This causes many preventableattacks and hospitalizations to occur, wasting millions of healthcaredollars year after year. Additionally, insurance premiums for asthmapatients remain potentially higher than if they achieved improvedcompliance.

Asthma medications are primarily administered through three differenttypes of inhalers: metered dose inhalers (MDI), dry powdered inhalers(DPI), and nebulizers. MDI inhalers include pressurized cartridges thata patient actuates by pressing down and breathing in while themedication is sprayed out of a nozzle. During dispensing, the pressureof the contents decreases as it enters the atmosphere. Due toGay-Lussac's law (P₁/T₁=P₂/T₂), the temperature of the canister alsodrops when the pressure decreases, causing a noticeable drop intemperature of the cartridge for each actuation of the MDI relative tothe atmosphere.

DPI inhalers come in several forms including the common disc shapedinhaler. The disc shaped inhaler contains several single dose capsulesof medication. These single doses are contained in packets evenly spacedalong a strip that is coiled around an internal gear. To dispense themedication, the patient first slides an actuator to uncover the nextdose on the strip while winding it into position near the mouthpiece.Next, the patient brings the inhaler to their mouth, and inhales deeply.The airflow created by the patient inhalation forces the powder to exitthe nozzle and enter the lungs.

Nebulizers deliver medication to a patient by vaporizing liquid drugsusing either pressurized air, ultrasonic vibration, or other modes e.For example, pressured air may be used to push the liquid through anozzle. In the case of the ultrasonic nebulizer, a piezoelectrictransducer may be used to produce vibrations that create a fine mist onthe surface of the liquid. Additionally, a mesh ultrasonic nebulizervibrates a mesh screen on the surface of a liquid creating a mist thatis inhaled. Accordingly, many different inhaler types for deliveringasthma medication exist, each with different methods of storing anddelivering medication.

The present disclosure relates to systems, methods, and kits forassisting asthma inhaler compliance and prevention. Embodiments will nowbe described with reference to the accompanying figures, wherein likenumerals refer to like elements throughout. The terminology used in thedescription presented herein is not intended to be interpreted in anylimited or restrictive manner, simply because it is being utilized inconjunction with a detailed description of embodiments. Furthermore,embodiments may include several novel features, no single one of whichis solely responsible for its desirable attributes or which is essentialto practicing the technology herein described.

Some systems for compliance monitoring can utilize mechanically actuatedswitches in order to confirm an inhaler has been used. In these devices,the device is integrated with the moving parts of the inhaler in orderto actuate the compliance monitor with the same patient force applied toactuate the inhaler. Thus, these systems are often customized and builtto conform to the physical characteristics of each inhaler type.Therefore, these systems can be physically complicated and expensive tomanufacture. Furthermore, these systems include moving parts andassociated openings that can be prone to contamination and wear andtear.

Accordingly, systems, methods, and kits have been developed formonitoring the compliance of an inhaler that are adaptable to a varietyinhaler types. These systems and kits can use some non-mechanicalmethods of verifying or detecting inhaler use. In some embodiments,these non-mechanical methods include monitoring and verifying at leasttwo different characteristics of the inhaler that are indicative ofusage.

Some systems and kits utilize motion sensing and temperature sensingcapabilities to determine whether the device has been actuated. Thisadvantageously provides confirmation of usage at two different stages ofinhaler actuation, which may eliminate a significant number of falsepositives. For example, if an inhaler is shaken in preparation foradministering medication, but not ultimately actuated, the temperaturesensor does not detect a change indicative of usage and thus the monitordoes not record a use. Accordingly, if the inhaler only detected themotion, a false positive may have been recorded. Similarly, if thecanister is actuated and the temperature decreases but the monitor didnot detect the prescribed shaking of the inhaler, the monitor determinesthat the patient inhaled the medication without properly shaking it inadvance.

In an example of a method for confirmation of usage, in the first stagea monitor may first detect motions that are characteristic of inhaleruse depending on the type of inhaler. For example, for an MDI inhaler,the monitor may detect the shaking motion prescribed prior to dispensingthe medication. For a DPI inhaler, the monitor may detect the actuationof the slider that breaks the medication powder capsule. For a nebulizerinhaler, the algorithm may detect the vibration associated with thenebulizer's piezoelectric transducer vibration. All of these motions maybe indicative that the user is preparing to use the inhaler.

Next, in a second stage of usage confirmation, the monitor may detecttemperature changes to validate use. For example, for an MDI inhaler,the monitor may detect a temperature of the cartridge to determinewhether the pressure dropped relative to the atmosphere to confirmactuation. In another example method, the monitor may detect temperaturechanges in or near a mouthpiece of an inhaler to detect the user'smouth. This provides additional confirmation that the user actuallybrought the inhaler close to their mouth to inhale the medication.Accordingly, this may eliminate a significant number of false positivesas a patient is unlikely to bring an inhaler close to their mouthwithout using the inhaler.

These are only examples of the monitors, kits, and methods for detectinginhaler usage. Many variations of these methods may be utilized toconfirm inhaler usage. These and other examples will be explainedfurther, as potential systems and methods for implementing an asthmacompliance management system.

Asthma Compliance Monitor System Overview

FIG. 1 illustrates an overview of an example asthma compliance monitorsystem 280. An asthma compliance system 280 may include an inhaler 100,an associated monitor 200, and a mobile device 150. “Monitor” is a broadterm that can be used as a noun and is entitled to its customary andordinary meaning. That meaning can include, without limitation, a systemfor monitoring (e.g., tracking, assessing, reporting, recording,analyzing, reminding, and/or notifying regarding) asthma compliance. Themonitor or a monitor system can include various components enclosedwithin a single or multiple housings in electrical communication withcomponents either aggregated on a single chip or spread across differentdevices at potentially different locations, and may include varioussensors, including temperature sensors, motion detectors, infra-redsensors, inductance sensors, accelerometers, gyroscopes, circuit boards,transmitters, wireless transmitters, and other components andconnectivity. For example, a monitor can be a package that includes bothmotion-sensing and temperature-sensing portions, which can bepiezo-electric. A monitor can also be a kit or collection of devicesthat collectively perform a compliance assessment function. For example,a monitor can include a mobile device with a processor that runs anapplication to coordinate or communicate the monitoring activities ofthe monitor. The term “monitor” can also be a verb and is used herein inits ordinary sense, which can include, without limitation, tracking,assessing, reporting, recording, analyzing, reminding, and/or notifyingfunctions.

As a patient uses an inhaler 100 in electronic communication with thesystem 280, each use (or each movement or temperature potentiallyassociated with a use) can be detected by the monitor 200, andtransmitted to a mobile device 150. Mobile device is a broad term, andis entitled to its customer and ordinary meaning and it includes,without limitation, mobile phone, iPhones, PDAs, iPads, tablets,laptops, desktop computers, devices connected to key chains, devicesconfigured to fit in a wallet or purse or other devices. Accordingly,the system 280 may compile usage data over time to process and evaluatethe usage for compliance and to alert the patient when a scheduled useis due.

Typical Inhaler Types

FIG. 2A illustrates a typical metered dose inhaler (MDI) that includes apressurized cartridge 105 filled with asthma medication and apropellant, a housing 115, and mouthpiece 110. The propellant is aliquefied gas that allows the medication to be delivered in aerosolform. The asthma medication is typically suspended or dissolved in thepropellant. When a patient actuates the cartridge 105 to breathe in themediation, the valve opens allowing the propellant and suspendedmedication particles to rapidly exit the mouthpiece 110 in tinydroplets. After exiting the nozzle, the propellant evaporates rapidlywhile leaving behind an aerosol mist of asthma medication. The patientthen deeply breathes in the aerosolized medication, which reducesinflammation of the lungs and dilates the bronchioles.

A patient is instructed to administer the medication with an MDI inhaler100 through a specific series of steps in order for the medication toproperly enter the lungs and reduce asthmatic systems. Particularly, thedensity of the propellant and the asthma medication are typicallydifferent, causing the two to separate inside MDI inhalers 100.Accordingly, a patient typically must first vigorously shake the inhaler100 immediately before use to ensure the asthma medication is evenlysuspended in the propellant. Next, a patient typically holds themouthpiece 110 near their mouth while squeezing the top and bottom ofthe MDI inhaler 100 together. This opens the metered valve on the MDI100 allowing the propellant and medication to exit. Once the pressurizedcontents exit the canister, the surface of the canister noticeably coolsdue to Charles law as discussed herein. Finally, the patient thenbreathes in the medication to allow it to enter their lungs and act ontheir bronchioles. Failure to shake an MDI inhaler 100 before dispensingcan result in the patient inhaling too small or large of a dose ofmedication as it may be distributed unevenly inside the cartridge 105.This is particularly troublesome for daily-dose asthma medication, whichdepends on consistence and regularity of treatments.

FIG. 2B illustrates a typically dry powdered inhaler (DPI). The DPIinhaler 100 actuates each dose through a mechanical lever and spoolingsystem. DPI inhalers 100 generally contain a coiled strip withindividual packets of medication. As a patient activates a DPI inhalerfor each use, the coiled strip is unwound to expose a new packet, thepacket is opened, and the patient breathes in the medication. Thepackets are enclosed by a foil covering that is continually peeled off,packet-by-packet, as the patient actuates the inhaler 100 for each use.The packets each contain a dry powdered form of medication that may bebreathed in by way of the airflow created by the patient's lungs.

A patient is instructed to administer the medication with a DPI inhaler100 through a specific series of steps in order for the medication toproperly enter the lungs and reduce asthmatic systems. Particularly,during operation, a DPI disc inhaler 100 must typically be held level,to prevent the powdered medication from clogging the inhaler ordispersing before inhaled by the patient. Additionally, the powder musttypically be in the appropriate position in order for thepatient-created airflow to force the powder into the patient lungs.

While holding the inhaler 100 level, a patient first presses on thethumb pad 125 to rotate the main body 140 of the DPI inhaler inside ofthe cover 125 in order to expose the mouthpiece 110 and a lever 130.This action creates a clicking sound and associated motion of the DPIinhaler 100. Next, a patient slides a lever 130 which rotates aninternal gear system, peeling off a covering of the next medicationpacket on the coiled strip and positioning the packet in front of anairway passage that exits through the mouthpiece 110. The sliding of thelever 130 creates an additional clicking sound and distinct motion ofthe DPI inhaler 100. The patient then brings the mouthpiece 110 to theirmouth, and inhales the medication to allow it to enter the lungs.

FIGS. 2C-2E illustrate examples of nebulizer inhalers 100. Nebulizerstypically include electromechanical or compressor-based methods oftransforming a liquid medication into an aerosol or droplets. Forexample, some nebulizers utilize a compressor that forces compressed airthrough a valve in fluid communication with the liquid medication. Thisdraws the medication through the valve and transforms it into a mistthat may be breathed in by a patient through a facemask or mouthpiece110. The medication may flow through a tube 112 to reach the mouthpiece110. Piezoelectric nebulizers are another example that are illustratedin FIG. 2D. These inhalers 100 typically use a piezoelectric system tovibrate liquid medication sufficiently to create a mist that may beinhaled. FIG. 2E illustrates a perspective view of an example nebulizerinhaler 100 that uses an internal piston compressor.

In order to administer medication with a nebulizer inhaler 100, apatient powers on the device by turning on the compressor or powering onthe piezoelectric element. This creates a distinct audible sound andvibration. Next, the patient brings the mouthpiece 110 toward theirmouth (extending the tube 112), and inhales the medication that hasmoved through the tube 112 to the mouthpiece 110.

A patient's use of each type of inhaler 100 typically requires adistinct series of movements or results in a series of movements,stages, sounds, temperature changes, environmental characteristics orchanges, and other things associated with the inhaler or its usage. Theinhaler may be evaluated by a monitor 200 attached to each type ofinhaler and analyzed to determine whether, when, and how an inhaler 100is used. Thus, the patient and health care providers may monitorcompliance with the prescribed dosing regimen, and provide the patientwith many additional benefits as described herein.

Accordingly, for each type of inhaler, examples are described herein ofhow the inhaler may be monitored and processed to confirm whether usehas occurred. However, these examples are only illustrations, and otheraspects of the inhaler or things associated with its usage may beadditionally monitored or validated. Moreover, these aspects may bemonitored or validated in different orders and logic sequences to trackusage and/or encourage proper dosing regimens. Finally, the variousexamples provided herein of particular types of inhalers 100 are merelyillustrative and the concepts described with respect to one inhaler type100 may be applied, if appropriate, to additional inhaler 100 types.Accordingly, the examples provided herein are not intended to belimiting or exclusive embodiments of an asthma inhaler compliancemonitoring system 105.

Compliance Monitor Design—MDI Inhaler

FIGS. 3A-3G illustrate various embodiments of the monitor 200 design andpotential placement on an MDI inhaler 100. (A monitor may includemultiple sensors packaged together—one or more may be configured todetect motion and/or orientation, one or more may be configured todetect heat, one or more may be configured to detect sound, the packagemay include some ability to process or convert signals from analog todigital or digital to analog, the package may include transmissioncircuitry, the package may include a memory to record sensor data,etc.). A manufacturer may configure the monitor 200 to be removablyconnectable to any appropriate location on an inhaler 100. Particularly,the monitor 200 may be placed in locations that are conducive tomonitoring characteristics indicative of whether usage has occurred. Insome embodiments, the monitor 200 may be permanently attached to aninhaler 100.

For example, the monitor 200 may be a cap or ring, connectable to thereplaceable cartridge 105 as illustrated in FIGS. 3A-3B. Thisconfiguration can take several forms, including a cap retained by amagnet connecting it to the metal cartridge 105. Additionally, the cap200 may have a rubber or friction mount that tightens or constrictsaround the cartridge 105. The opening of the cap 200 may include acylindrical opening sized to allow for the cartridge to be insertedinside the cap.

In this configuration, in addition to measuring motion and sound, themonitor 200 can sense the casing temperature of the cartridge 105. Thisis due to the fact that the monitor 200 is in tactile contact with andrigidly coupled the cartridge 105. Thus, a cartridge thermal sensor 230can be positioned to sense the cartridge 105 temperature. Thisadvantageously allows the system 280 to confirm that medication hasactually been dispensed and can provide additional confirmation thatusage has occurred.

Additionally, the amount the temperature of the cartridge 105 decreasesmay be correlated to the amount of medication dispensed. Thus, theamount of aerosol and medication that exited the cartridge 105 may beapproximated based on a reading from the temperature sensor. Finally,this data can be validated with audio data including by detecting thesound of the aerosol exiting the mouthpiece 110. From this data, whetherthe metered dose properly delivered the correct quantity may bedetermined. For example, an empty or nearly empty cartridge 105 may notdeliver as much aerosolized medication, prompting the system to delivera warning to the patient.

Furthermore, the cap or ring 200 connected to the cartridge 105 mayincorporate an infra-red oral thermal sensor 225 aimed towards themouthpiece 110 to potentially detect whether a user's mouth comes withinclose proximity to the mouthpiece 110. Also, the thermal sensor 225 maydetect heat changes caused by inspiration and exhalation. For example, apreparatory exhalation near the inhaler may cause the temperature torise due to condensation or the temperature of air exiting the lungs.Upon inspiration, the temperature may then decrease due to evaporationor cooler air entering the mouth and being sensed by the thermal sensor225. Additionally, the infrared oral thermal sensor 225 may be aimed atdetecting heat signatures of other parts of the face, including theeyeballs, nose, and forehead.

A health care provider may advantageously configure the monitor 200 tosense when it is removed from an inhaler 100. Capacitance sensors,mechanical push button monitors, infra-red range sensor or othersuitable sensors known in the art can be used to determine when themonitor 200 is removed and attached to a new inhaler 100. Once themonitor 200 has been replaced, a notification can pop up on thepatient's mobile device 150 requesting the patient confirm whether themonitor 200 has been installed on a new inhaler. This feature isadvantageous to alert the refill monitoring system 800 that a refill hasbeen inserted and to restart the usage count.

In addition to placement on the canister, the monitor 200 may also beplaced on the housing 115 of the inhaler 100. This may be accomplishedthrough a ring configuration, a cap configuration or other suitablemechanical components for connecting the monitor 200 to the housing 115.Additionally, in any configuration, a monitor 200 may be removablyconnectable to an inhaler 100.

While connected to the housing 115, the monitor 200 may detect thetemperature drop of the canister 105 with a probe, or the associatedtemperature drop that is transmitted through the housing 115.Furthermore, infrared sensors may be used to sense mouth or facial heatsignatures. The monitor 200 may also have a motion sensor to detect themotion signature typical for removing the cartridge 105 from the inhaler100.

A manufacture may also configure a monitor 200 to be connectable to aninhaler 100 near the mouthpiece 110 as illustrated in FIG. 3D. In thisconfiguration, in addition to the other characteristics described abovethat can be detected, a monitor 200 can be placed in an advantageouslocation to detect the heat signature from a patient's mouth during use.For example, a monitor 200 may have an infra-red temperature sensor 225aimed along the line of sight of the mouthpiece 110. Thus, when apatient opens their mouth to use an inhaler 100, the infra-redtemperature sensor 225 detects the increased temperature inside themouth. This can be particularly advantageous, as the mouth typically hasa higher temperature than a patient's surrounding skin. Accordingly,placement of the monitor 200 alongside the mouthpiece 110 can allow themonitor 200 to have an advantageous line of sight to a patient's mouth.Additionally, with the monitor 200 in this location, or other locationsdescribed herein, the monitor 200 may also include a contact, oralthermal sensor 225 that may be placed near the mouthpiece 110.Accordingly, the oral, thermal sensor 225 may then detect thetemperature increase caused by the patient's mouth during use due tocontact of the mouth with the oral, thermal sensor 225. In thisconfiguration, the monitor 200 can also detect sound, motion,temperature of the housing 115, and the additional characteristicsmentioned for other configurations and types of monitors herein.

A manufacturer may also configure a monitor 200 to be in the shape of aclip as illustrated in FIGS. 3E-F. In this embodiment, the monitor 200may include a slender portion 205 of a clip monitor 200 that slidesbetween the inhaler cartridge 105 and the inhaler housing 115. The clipmonitor 200 may include an oral or infra-red temperature sensor 225. Theinfra-red sensor 225 may be connected near the end of a slender portion205, in order to be placed near the opening of the mouthpiece 110.Additionally, the infra-red sensor 225 may be aimed out the mouthpiece110 from inside in a direction that allows the infra-red sensor 225 todetect the heat signature of an open mouth or inhalation and exhalationduring administration of medication. Additionally, a temperature sensor225 may be located on the portion of the monitor 200 not containedinside the inhaler housing 115. For example, the temperature sensor maybe located in a position that has a line of sight to a patient's mouthwhile a patient is inhaling medication. The clip monitor 200 may fastento the inhaler housing 115 by pressure created by a plastic or springloaded hinge incorporated into a clip incorporated into a monitor 200.This pressure may be created between a slender portion and anelectronics compartment 245 once the clip monitor 200 is attached to theinhaler housing 115. The electronics compartment 245 may enclose some ora majority of the electronics of the monitor 200. The electronicscompartment 245 may be connected to the slender portion 205 and may beconfigured to sit outside the inhaler housing 115.

Compliance Monitor Design—DPI Inhaler

FIGS. 4A-4I illustrate examples of monitors 200 configured to detectusage of a dry powdered disc inhaler 100 (DPI). A manufacturer mayconfigure a monitor 200 to be connected to various appropriate portionsof a DPI inhaler 100. For example, FIG. 4A illustrates a monitor 200connected to a cover 125 or top portion of the DPI inhaler 100.Placement on the cover 125 can allow a monitor 200 to avoid interferencewith the moving parts when the main body 140 of the inhaler 100 isrotated within the cover 125 (e.g., using the slideable lever 130).

In some examples, the monitor 200 may be constructed with a slim enoughprofile to be connected near the mouthpiece 110 or other areas of themain body 140 of a DPI inhaler 100. For example, FIG. 4B shows a monitorattached to the side of the DPI inhaler not far from the mouthpiece 110.A monitor 200 may exhibit a low enough profile to avoid interferencewith the cover 125 when it is rotated back over the mouthpiece 110 andlever 130. Placement near the mouthpiece 110, as described above forother types of inhalers, can allow contact or infra-red, oral, thermalsensors 225 in electrically communication with monitor 200 to detectpresence of the open mouth.

A monitor 200 may also be configured to clip on to a lever 130. Thisconfiguration can allow the monitor 200 to detect the motion of lever130 as it is slid forward to actuate the inhaler 100. Also, the motionand sound created by the click is advantageously detectable in thisconfiguration. Furthermore, in this location, a monitor 200 may alsodetect the temperature of the open mouth through temperature monitors asdiscussed herein and detect clicks and audio sounds that typicallyaccompany actuation of the DPI inhaler 100.

A monitor 200 may additionally be configured as a clip that fits overthe top and bottom portions of the DPI inhaler 100 as illustrated inFIGS. 4C-E. The clip is illustrated alone in FIG. 4C. The clip isillustrated as attached to a DPI inhaler in the example of FIG. 4D, anda side view of this same example is shown in FIG. 4E. The clipconfiguration may include capacitance sensors on the top, bottom or onboth positions that sense when a conductive medium touches the inhaler100, such as human hands in preparation for usage. This capacitance datamay provide an additional or substitute confirmation of usage asdiscussed herein. Additionally, various sensors may be integratedthroughout the clip housing. In these figures, an oral temperaturesensor 225 is helpfully located and oriented with a good vantage pointnear the mouthpiece 110.

The design illustrated in FIGS. 4C, 4D, and 4E can be particularlyuseful because: it can be easy to install and remove; it can use lessraw material and is therefore potentially less expensive to manufacture;it has a small profile and may be less intrusive to a user; it can havean easily-removed mount to the housing and avoid use of adhesives; themethod of dosing medications can be unchanged from instructions providedby the DPI manufacturer; it can support a temperature sensor positionedwell for pointing toward the face or mouth of a user; the opening andclosing movements of a user can remain the same as they would be withoutthis attachment.

The monitor 200 may be configured to cover much or most of the entireDPI inhaler cover 125 as illustrated in FIG. 4F-4I. These embodimentsare advantageous because the monitor 200 is reliably attached to theinhaler cover as the sensor covers the entire DPI cover 125. The varioussensors, including capacitance sensors, may be integrated throughout.

The embodiment of FIGS. 4F and 4G can create an all-in-one device thatwould simply slide onto an DPI such as a Diskus inhaler. As shown in thefigures, it feels and looks similar to the cover that the Diskuscurrently has but allows external sensors without the user having toworry about placement. These sensors may include contact temperaturesensors, temperature switches, microphones or any other type of sensor.It can be designed to include a housing/mount interface or be anall-in-one device. The IR sensor can be pointed toward the users face.The design could help inhibit improper installation. The embodiment ofFIGS. 4F and 4G can have the following features and advantages: easy toinstall and remove; it may include external sensors; it would providespace for inclusion of specific instructions to a user; it can be amount/housing interface or an all-in-one housing; it can employtemperature switches for power saving; it can allow users to use thesame dosing protocol and actions; and it can avoid a need for users toplace any external sensors.

FIG. 4H and FIG. 4I show an embodiment having a cover that encompassesthe whole Diskus (except for said mouth piece). The monitor 200 mayinclude a door that may open and close to cover and/or reveal themouthpiece 110. The door may open and close as needed for a patient todispense the medication from the inhaler 100. Additionally, the door maycontain its own motion sensor 210 and the sensor 200 body may alsocontain a motion 210 and relative motion between the two sensors may beindicative that the door is being opened. As indicated in FIG. 4H, thedoor may be opened by a sensor lever 275 connected to the sensorhousing. Accordingly, detection of rotational motion a certain angle θof sensor lever with respect to a sensor cover would indicate theinhaler 100 has likely been used. Example sensors useful for thisembodiment can include, e.g., an accelerometer, magnetometer, gyroscope,and IR temperature sensor. In the plan view of FIG. 4H, dashed linesindicate the hidden shape of the DPI inhaler underneath the examplemonitor 200 that surrounds and encloses nearly the entire DPI inhaler.

FIG. 4I illustrates a schematic cross-section view of an example of aconstruction of a monitor 200 that covers the entire DPI inhaler cover125. The monitor 200 includes two halves that may be snapped togetherwith the illustrated hook system or any other suitable mechanical,magnetic, or other connection.

The design illustrated in FIG. 4H and FIG. 4I can be particularly usefulbecause: its full coverage and extensive coverage allows placement ofone or more external sensors where they may be desired; sensors can bepre-installed by a manufacturer with no requirement that users positionsensors; a user only has to perform one additional action—use the leverto open the cover; installation can be simple (e.g., only one way tofit) and inhibit the potential for errors; there may be a reduced needfor an external gyroscopic sensor if the housing itself moves; atemperature sensor can rotate, thereby allowing the sensor to sense atemperature gradient (if the sensor has a cover, this gradient can beamplified); the cover may be secure and unlikely to be dislodgedinadvertently; it can helpfully obscure instructions from the originalDPI provider so that the updated instructions that account for use ofthe cover are more prominently accessible and/or visible to a user.

FIG. 4J illustrates how some embodiments can have a sensor or group ofsensors together in a single disk-shaped attachment that is secured topiggy-back directly on the flat back of the DPI. This design can berelatively minimal. This design contains a window for IR temperaturesensor(s) such as those described above with respect to other designs.Installation may include proper alignment before adhesion. Sensors thatcan be included for effective use of this low-profile design can be anaccelerometer, an IR temperature sensor, and a microphone. The designillustrated in FIG. 4J can be particularly useful because: it is lowprofile and non-intrusive; it does not alter usage of the underlyingDPI; it involves few materials and can therefore involve lowmanufacturing costs; it can readily orient a temperature sensor towardthe face and/or mouth.

Compliance Monitor Design—Nebulizer Inhaler

FIGS. 5 and 6 illustrate examples of a monitor 200 integrated configuredto detect usage of a nebulizer inhaler 100. A manufacturer may configurea monitor 200 to be removably connectable to various locations along anebulizer inhaler 100. For example, the monitor 200 may be placed nearthe mouthpiece 110. This placement can facilitate thermal detection ofthe open mouth during usage as discussed herein.

Additionally, a monitor 200 may be placed on a compressor 120 that maybe associated with the nebulizer inhaler 100. In this configuration, amonitor 200 may detect the vibration and noise generated from thecompressor to verify use. As discussed above, a nebulizer inhaler 100has a motion generating element that creates significant noise. Amonitor 200 may monitor these elements to record the total time thenebulizer inhaler 100 is in use. In a configuration where the monitor200 is attached to the compressor 120, the manufacturer may also includea probe that is wired or wirelessly connected to a mask or mouthpiece110 associated with the nebulizer inhaler 100. Integrating a probe nearthe mouthpiece 110 will allow the monitor 110 to confirm usage bydetecting the heat signature of the mouth or facial area, once the userbreathes through the mouthpiece 110 or facemask. Additionally, themonitor 200 may include a humidity sensor 550 that can detect increasedhumidity from the mist created through the nebulizer inhaler 100 or fromthe patient exhaling.

Monitor 200 is a broad term, and may include self-contained monitoringequipment stored within a housing, separate components and sensors thatare physically divided but operate in conjunction through electroniccommunication, multiple sensors packaged together as described above, orother configurations. Manufactures may construct a monitor 200 from anysuitable materials including, biocompatible medical grade material,water resistant materials and constructions, plastics, metal, or othersknown in the art. In some embodiments, manufacturers will fabricate amonitor 200 to be completely self-contained with no moving parts toremove openings that may become contaminated or decrease the life ofmonitor 200. Particularly, a monitor 200 may not have any mechanicallyactuated usage sensors such as a switch. Accordingly, a monitor 200 maybe designed to avoid moving parts, which can allow it to be sealed toliquids, moisture and other contaminants during operation. Includingfewer moving parts can also decrease the chances of mechanical failure.

Overview of Compliance Monitor Design

FIG. 7 illustrates an overview of an example of the some components thatmay be incorporated into a monitor 200. The monitor 200 may include acontroller 235 that controls the various functions of the monitor 200.Controller 235 is a broad term and may include any computing device orsimple circuitry for executing instructions, including but not limitedto, microcontrollers, microprocessors, and others. Controller 235 may bea master controller 235 or a slave controller 235 that is directed byanother computing device in electronic communication with the controller235.

The monitor 200 may include various temperature sensors as illustratedin FIG. 7. For example, the monitor 200 may include an oral temperaturesensor 225. An oral temperature sensor 225 may be any temperature sensorthat is configurable to measure or detect the thermal increaseassociated with the close proximity of a patient's mouth to a mouthpiece110 or mask during use of an inhaler 100, or from inhalation andexhalation. For example, the oral temperature sensor 225 may incorporatean infra-red thermal sensor that is aimed in a direction that has aclear line of sight to a patient's mouth when opened in position forinhaler 100 usage. In addition, the oral thermal sensor 225 may also bea contact sensor that can sense the temperature of the patient's mouthcontacting a mouthpiece 110. Oral temperature sensor 225 may be anysuitable thermal sensor.

The monitor 200 may also incorporate a cartridge temperature sensor 230.A cartridge temperature sensor 230 may be any suitable temperaturesensor. For example, a cartridge temperature sensor 230 may be aninfra-red temperature sensor that is aimed at the surface of thecartridge 105. This configuration can allow the cartridge temperaturesensor 230 to be placed remote from the cartridge 105 while stillsensing its temperature. For example, if the monitor 200 is placed on amouthpiece 110, the cartridge temperature sensor 230 may be aimed at thecartridge 105, while the oral temperature sensor 230 can be aimed at thelocation of the open mouth during usage. Additionally, cartridgetemperature sensor 230 may include a probe connected with a wired orwireless connection to monitor 200. In some embodiments, cartridgetemperature sensor 225 may be a contact thermal monitor placed near thecartridge 105.

The monitor 200 may also include an ambient temperature sensor 220. Anambient temperature sensor 220 may be any suitable temperature sensor,including thermometers, thermistors, and others. Data derived from anambient temperature sensor 220 may be useful to compare with the datafrom an oral temperature sensor 225 and the cartridge temperature sensor230 to validate usage.

The monitor 200 may also include an audio sensor 215, for detecting thesounds generated by a patient and inhaler 100 during use of the device.For example, an audio sensor 215 may detect sound waves created byinhalation of the patient during usage, the clicks of the DPI inhaler100 during usage, aerosol exiting the MDI inhaler 100, operation of thegenerator or piezoelectric motors in the nebulizer inhaler 100, andother sounds indicative of use.

A monitor 200 may also incorporate various motion sensors known in theart. For example, the monitor 200 may incorporate an accelerometer,gyroscope, magnetometer, acceleration switches, tilt switches, or anyother motion and orientation sensing device that is known in the art orhereinafter developed. Incorporation of motion sensors 210 will allow amonitor 200 to detect certain movements and orientations of an inhaler100 with respect to gravity that are characteristic of or required forusage. These movements will vary for each type of inhaler 100, and thealgorithms for analysis may be modified accordingly depending on thetype of inhaler 100.

The manufacturer of a monitor 200 may also incorporate various visualand audio displays and alerts. For example, audio and visual alert 240capabilities may be included with speakers, LEDs, or other notificationsystems and methods known in the art. Additionally, a monitor 200 mayinclude a display 260. A display 260 may include a full LCD screendisplay, or a simple analog or digital readout. In some, embodiments, amonitor 200 has no display 260.

A monitor 200 may also incorporate a battery 270 and memory 265. Thebattery 270 may be any suitable battery, including a CR2032 button cellbattery or others. The memory 265 may be any suitable data storagedevice, including volatile memory types such as random access memory,DRAM, SDRAM, and others. If volatile memory is utilized, monitor 200 maycontinually transmit information to an associated component of thesystem 280 in order to store data collected by monitor 200. Memory 265may also include non-volatile memory, including read only memory,EEPROM, flash memory, optical and magnetic computer memory storagedevices, and others.

The memory 265 may store computer modules or other software forimplementing the functions of monitor 200 described herein.Additionally, memory 265 may store data collected by the various sensorsassociated with monitor 200. This data may be continually transmitted toassociated devices for long term storage or stored on memory 265 untildownloaded by connecting another device to monitor 200. In someembodiments, monitor 200 may be a self-contained unit that includescompliance monitoring software and sufficient memory 265 to store usageand sensor data for a patient.

A manufacturer may also include electronic communication systems andmethods for monitor 200 including a wired 155 and wireless link 250.Wireless link 155 may incorporate any suitable wireless connectiontechnology known in the art, including but not limited to Wi-Fi (IEEE802.11), Bluetooth, other radio frequencies, Infra-Red (IR), GSM, CDMA,GPRS, 3G, 4G, W-CDMA, EDGE or DCDMA200 and similar technologies.Additionally, the systems for electronic communication may include awired connection 255 or various ports, including RS-232, or otherstandard communication technology known in the art.

Compliance Monitor Mobile Application

FIG. 8 illustrates a monitor 200 in wireless communication with anapplication 300 installed on a mobile device 150. This configurationadvantageously permits, in some embodiments, the data compilation andanalysis to be performed on a patient's mobile device 150 or on othersystems in communication with the application 300 on patient's mobiledevice. Additionally, integration with a mobile device 150 can allow themonitor 200 to utilize the various sensors and other capabilitiesalready present on many mobile devices 150 including location sensingcapability, date and time recording and association with individualuses, and connection to the internet. A monitor 200 may be incommunication with an application 300 on mobile device 150 throughwireless link 250 or a wired connection 255. In some embodiments, amonitor 200 transmits usage data collected via sensors or processed bycontroller 235 and associated modules.

Additionally, application 300 may send instructions to controller 235 orprovide new firmware or software to monitor 200. For example, if userpurchases a different type of inhaler 100, the application 300 mayprovide an option for downloading appropriate algorithms and logic fordetermining usage tailored to the new inhaler. Additionally, anapplication 300 may send instructions to activate audio or visual alerts240, to present certain information on a display 260, or to power on amonitor 200.

An asthma compliance monitoring system 280 may include logic to evaluatewhether use has occurred based on certain characteristics sensed by thesensors and sensors of a monitor 200 that are associated with use. Thelogic and characteristics detected to evaluate use vary and also may bemodified to accommodate particular types of inhalers 100. Accordingly,the examples described below are merely illustrations, and the featuresof the various examples given may be interchanged, switched, replaced,combined, and modified appropriately.

Example Hardware Features Device

Various products and systems can be made according to this disclosure.Some relevant products can leverage existing computational poweravailable in smart phones, for example, by providing a small hardwaremodule that can communicate wirelessly with a smart phone running asoftware application. Such a system's objectives can include the abilityto detect the usage, by an individual, of one or more asthma medicationmodalities, which may include the Metered Dose Inhaler (MDI), DiskInhaler (Diskus) and the Nebulizer. As noted above, different mountingstructures can be provided that allow a small hardware module (see,e.g., the monitor 200 of FIGS. 16 and 17) to attach to various styles ofinhaler. Such a universal sensor can house several different sensorswhile having pins to interface with external sensors.

Some basic features of a modular commercial device (an example of whichmay be referred to as the “ClickSonea” device) that may exhibit some ofthe advantages discussed herein, may include those set forth below. Thedevice can pair with a smart phone via Bluetooth. Once paired, thedevice may send data to the smart phone automatically. The device may beable to be mounted on three different asthma medication devices; themetered dose inhaler, the disk inhaler and the nebulizer. While mounted,the device may be able to detect and recognize when the device has beenused or is currently being used by the individual depending on themedication device in use. Various sensors may be used to determine whenthe device has been, or is being, used; multiple sensors may be usefulto filter out false positives. Data received from the sensors may beprocessed on-board the device. Data may be sent from the device to aportable computing device (e.g., operating on an Android or iOSplatform) via a wired or wireless protocol (e.g., a Low Energy Bluetoothconnection, Bluetooth (BLE 4.0), etc.); data sent to the smart phone caninclude a timestamp and the medication used.

It will often be advantageous to mount a modular device (such as the onediscussed above) on an inhaler. Many approaches to mounting areadvantageously tightly and rigidly mechanically coupled with respect toa physical, rigid out portion of an inhaler. This is helpful if themodular device includes motion sensors such as accelerometers,gyroscopes, and the like because a close mechanical coupling can helpprovide more relevant data: when the inhaler moves, tilts, etc., themodular device moves, tilts, etc. in the same manner or direction.

Systems such as described herein can be especially useful if they takeinto account human factors. For example, the design can advantageouslyaccount for users taking their medication via: a metered-dose inhaler(medications can be controller medication, as-needed medication, and/orrescue medication); a disk inhaler; and/or a nebulizer.

When mounted on a MDI, for example, a modular device may be able torecognize: the inhaler being shaken; and/or that the inhaler is being orhas been pressed (e.g., without requiring the use of a button). For adisk inhaler, a device may be able to recognize: the opening and closingof the disk; when the medicine has been dispensed (through recognitionof lever being pushed); when the disk is being held up to the usersface; and/or when the disk (or device) is being held parallel to thehorizontal axis. When mounted on an asthma nebulizer, the modular devicemay be able to recognize: relative change in humidity while thenebulizer is being used; change in temperature of the nebulizer tubeswhile the user is breathing through the device; when the device is beingheld up to the user's face; and/or when the device is turned off.

Some embodiments of a hardware device may be referred to as a“ClickSonea” device and may have the following physical description:dimensions (of MDI version): no greater than (10×27×18 mm); weight: Nomore than 30 grams; attachable (and, potentially, detachable), to andfrom, each individual inhaler type; all parts may be made out ofbiocompatible medical grade material; shaped as a rectangular prism withthe dimensions given above; water resistant.

Some embodiments of a hardware device meet the following environmentconditions: ambient operating temperature: Range of 0° to 60° C.;storage temperature: Range 20° to 25° C.; humidity: 0-70% RH; altitude:−200 m to +2000 m.

The hardware can include a printed circuit board (e.g., as part of or tointerface with a microcontroller). To be environmentally-friendly, thePCB (Printed Circuit Board) may comply with RoHS lead-free standards. Itmay consume no current during off time from the main battery. The devicemay contain a single PCBA (Printed Circuit Board Assembly), whichcontains sensors, an embedded microcontroller and a digital to digitalconverter. In some cases a digital to digital converter can be usedbecause the CC2541 SensorTag Dev kit uses such a converter. Other boardsbased on the 8051 MCU, for example, may also employ a digital to digitalconverter.

Power Management

The device may have a replaceable battery, or in some embodiments, itmay not have a replaceable battery and may be discarded after thebattery dies. The battery itself may last an appropriate length of time.For example, it may be designed to last around a year. It may beselected or configured to last for the entire lifespan of the longest ormost demanding medication type. For example detecting a shake event 200times for a metered dose inhaler may be the most demanding. In someembodiments, the device may have: a CR2032 button cell battery; anaverage battery 1 of year of use; and/or low power consumption.

Regarding consumables/disposables, the hardware may be a ‘green’ device.It may meet biocompatible standards. The battery life may be at leastone year, for example. Meeting these standards, the device may bedisposable after the battery life is ended and a new one may be bought.The device may be designed to be an affordable and disposable solutionfor tracking asthma medication use. Regarding reliability, the mean timebetween failures (MTBF) of the device may be longer than 30,000 hours.(This may be wall clock hours or use hours).

Example Software Features Application

A software application can be used to communicate with and processinformation from the modular hardware device described above. Thesoftware may, for example, be referred to as a “ClickSonea App.” Thesoftware may be: qualified by one or more smart phone manufacturers;launched automatically once the hardware device is paired with the smartphone; and/or the main console for the operator. The softwareapplication may provide all necessary instructions. The softwareapplication may allow an operator to initiate a data collection sequenceby use of a predefined action (such as shaking the MDI). Moreover, asoftware application may gather data on whether the inhaler device hasbeen, or is being used; forward the validated data to a web portal forfurther analysis; display any feedback to the user upon reception fromthe web portal; allow operators to be authenticated before accessing thesoftware application; and/or allow communication between the softwareapplication and web portal to be encrypted.

Example Software Features Web Portal

A web portal related to the above software and hardware may: provide fora web interface for operators to manage their accounts; allow forstorage of some or all uploaded data into a secured database; providefor authentication of all access to the web portal; allow users toremotely access their account and billing information via a special or aregular web browser. All traffic may be encrypted.

A user interface of the above hardware and software (which can togetherbe commercialized under the name “ClickSonea System”) can provide forrecording of time a stamp and location of each medication usage and beeasy to use. The software as visible on a mobile phone may act as themain console interfacing with the operator. The software thus visiblecan, for example, announce status such as: out of battery, etc.

The example hardware and software systems described here can connect tothe following platform as hosts: Apple (iPhone 4S and 5; iPad (4thGeneration), iPad mini; iPod Touch Gen 5); and/or Android (variousdevices on various platforms such as Jelly Bean 4.3). The web portalcan, for example, be designed to be compatible with the followingplatforms: Linux 2.6; Apache 2.x; MYSQL 5; PHP 5; and/or Zend Framework2.

For security purposes, the hardware and software systems comply withHIPAA, FDA and QSR requirements.

Example Hardware and Software Functionality

Once powered up, tested and configured initially, the modular hardwaredevice described above may be ready to pair with the smart phone. Oncepaired with a smart phone via Bluetooth, the software application maygain control over the hardware device. Data may be received inreal-time. When a USB connection is found during power cycle, thehardware device may enter into a TEST state for testing/diagnostics oncethe hosted PC is authenticated. The device may be power cycled afterproduction testing. Firmware of the hardware device could bereprogrammed during the TEST state. If the device is not connected tothe smart phone via Bluetooth, the device may store the data and sendonly when the Bluetooth connection is reestablished.

The software application may be capable of gathering data from thehardware device, forwarding data to the web portal, and displaying anyfeedback. Though the software gathers data from the hardware deviceautomatically, the user may also be able to input their own data in casethe system does not detect a usage at the appropriate time. When thehardware device detects that the inhaler has been used it may ask forconfirmation from the user in order to filter out false positives.

The web portal may: provide account and billing management forauthenticated operators; log measurement results on designatedClickSonea Web accounts; and/or be compatible with a web portal such asthe AirSonea Web Portal. A single user name and password may be neededto view data (e.g., data derived from and or visible to or fromdifferent devices—the modular hardware, a smart phone running thesoftware application, or another machine running the software or storingrelated data). User names, passwords, and central user accounts mayfacilitate payment options and managing accounts. A web portal may allowthe user to remove their data from the database and it may allow usersto close their account.

Sensors in the Example Hardware

The module device hardware described here can include sensors. Locatingthe sensors within the device itself can be helpful to avoid tampering.Hardwired sensors can also avoid a need for a user to performcalibrations. In some embodiments, once the device is attached to theappropriate mount all that is needed is to use the medication as normal.The device may have an accelerometer, gyroscope and magnetometer onboard. These sensors may be used individually to detect specificmovements or in combination to detect change in relative position in 3-Dspace. In order to detect temperature and temperature changes, thedevice may include an on-board IR temperature sensor.

In order to achieve the above features and functionality for thehardware, software, web portal, and system, multiple sensors may beused, which may be on-board and/or external to the modular hardwaredevice. The sensors may interface with the system: (1) the on-boardsensors may interface directly with a CC2541 System-On-Chip (SOC)through an I2C interface (e.g., an inter-integrated circuit such as amultimaster serial single-ended computer bus used for attachinglow-speed peripherals to an embedded system); and/or (2) externalsensors may interface via GPIO, or some other pin interface, with themodular hardware device.

FIG. 9 illustrates an example system architecture diagram for thesensors. A power source 410 (e.g., a CR 2032 battery) can interface orcommunicate with a converter 412 (e.g., a DC/DC TPS 62730). A processor414 (e.g., a CC2541 system-on-chip) can interface with other devicesusing GPIO pins 416, for example. External sensors 418 can communicatewith the processor 414 via the pins 416. Such sensors 418 can includecontact sensors, for example. A switch 420 can be a tilt switch. It canhelp determine when the processor 414 should draw power from the powersource 410, thereby allowing the processor 414 to maintain a sleep modeat relevant times, saving energy. An alert system 422 can be a feedbacksystem of any kind, such as a visual alert system comprising one or morelight-emitting diodes. The processor 414 can be use an I2C interface(e.g., an inter-integrated circuit) to communicate with one or moresensors, such as an accelerometer 424, a gyroscope 426, a magnetometer428, an IR temperature sensor 430, and or other sensors 432. Each of thespecific items in this figure is merely an example. Thus, e.g., in placeof or in addition to the CC2541, another processor and/ormicrocontroller can be included.

In the context of FIG. 9, a system may include the following specificsubsystems: (1) multiple MEMS sensors (e.g., sensors 424-423) including,but not limited to, IR temperature sensor 430, accelerometer 424,gyroscope 426, magnetometer 428, and humidity sensor; (2) on-board flashprogram memory capable of being programmed by USB connection to a hostcomputer. (This programming feature can be the same or similar to theTEST mode referred to earlier. It can be used for firmware updates, forexample. This function may be available for end-users, a manufacturer,and/or a health-care provider, for example); (3) bluetooth interface;(4) tilt switch (e.g., switch 420); and/or (5) LED element that aids incommunicating the status of the device to the customer (ready, done,power on, etc.)—e.g., alert system 422.

FIG. 10 illustrates an example of how a modular device may be able tointerface with different types of inhalers and may be able todistinguish between them. In order to effectively filter out falsepositives, it may be helpful to have external sensors on the mounts forthe different inhalers. These sensors may provide additional data to themodular device and may not necessarily be needed for all inhalers. InFIG. 10, a microcontroller 440 is physically associated with a modulardevice housing 442. The microcontroller 440 can communicate with and/orbe attached to external sensors 454, 464, and 474. Various detachableinterfaces 444 can be used to associate the modular device housing 442with an MDI mount 450 (which, in turn mounts to a metered dose inhaler452), a disk inhaler mount 460 (which, in turn mounts to a dry powderdisk inhaler 462), and/or a nebulizer mount 470 (which, in turn mountsto an asthma nebulizer). The mounts and interfaces referred to here canbe those illustrated in the figures above, for example. Each mount canhave an associated external sensor, as shown with the lines connectingthe MDI mount 450 to the sensor 454, the disk inhaler mount 460 with theexternal sensor 464, and the nebulizer mount 470 to the external sensor474.

Regarding signal acquisition, processing, and communication, the devicemay accept data from, for example, 4 sensors (IR Temp., Gyro, Accel, andMagnetometer). Other sensors may be added through GPIOs in order tocapture specific data from specific devices). The signals captured fromthe data may be processed on-board the microcontroller on the device.All data may be processed in real time. The device may communicate viaBluetooth 4.0 to smart phone devices. It may interface with the on-boardsensors via an I2C bus and external sensors via GPIO pins.

Combined System Overview

FIG. 11 illustrates an example system overview of how a device 480,software application 486 running on a portable electronic device such asa smartphone 484, and web portal 490 can work together. The device 480can be attached to multiple types of asthma inhalers (e.g., theillustrated metered-dose inhaler 456, disk inhaler 466, and/or nebulizer476). The device 480 can keep track of medication usage through the useof different MEMS (micro-electronic mechanical sensors). The sensorsinclude, but are not limited to, IR temperature sensor, humidity sensor,accelerometer, gyroscope, magnetometer, and a contact temperaturesensor. The device 480 may gather data from these sensors and run theappropriate algorithms to check if the inhaler has been, or is being,used. The confirmation of the inhaler being used may be sent to thepaired smart phone 484.

Resident in the memory of a smart phone 484, the software application486 may interface with the device 480 (e.g., wirelessly using Bluetooth4.0). The software can provide the main console interfacing with theuser. Data from the sensors may be processed and use of the inhaler maybe detected. Notification of inhaler use may be sent to the smart phone,which may in turn forward this information to the web portal 490 via anetwork 310 (e.g., through the internet or a worldwide web connection).

The web portal 490 can be a cloud server running on the internet. Uponreception of the confirmation data from authenticated operators, the webportal 490 (and/or a processor associated therewith) may analyze thedata and store it in a database 492. This database can be accessed andit may return and display feedback to the user through the softwareapplication 486.

The system described herein may be helpful for use in both clinical andhome environments. It is helpful for a single patient, multiplemedication use device to provide medication usage information. Thesystem is useful for both pediatric and adult patients, for example.

Safety and Regulatory Considerations

The systems described herein may meet standard medical and consumersafety standards and may comply with electrical immunity andsusceptibility standards. They may meet the following standards:Biological Evaluation of Medical Devices (Biocompatibility), ISO10993-1:2003; MDD Council Directive concerning medical devices,93/42/EEC; Safety of Medical and Dental Equipment, UL 2601-1; GraphicSymbols for use in the Labeling of Medical Devices, EN 980:2003;Information supplied by the manufacturer with Medical Devices, EN1041:1998; Clinical Investigation of Medical Devices for Human Subjects,EN ISO 14155:2003; Clinical Investigation of Medical Devices for HumanSubjects, BS EN 540:1993; Test of immunity from electrostatic discharge(ESD), IEC 801-2:1994; Electrical Fast Transient/burst,IEC61000-4-4:1995; Safety requirements for electrical medical devices,EN60601-1:2003; Medical Electrical Equipment Electromagneticcompatibility, EN60601-1-2:2002; FCC Part 15 Certification; BluetoothQualification.

The systems described herein may also satisfy regulatory constraints andfeatures, such as: USA: FDA 510(K) OTC; European Union: CE-Medical mark;Australia: TGA. Regulations of other countries, such as Israel, China,Japan, and Brazil can also be satisfied.

Evaluating Inhaler Regimen Compliance

FIG. 12 illustrates an example of a method for evaluating whether apatient has used an inhaler 100. While FIG. 12 illustrates a sequence ofsteps for evaluating usage of an inhaler, the potential methods forevaluating compliance should not be limited to those disclosed in FIG.12. First, a patient generally will pick up their inhaler 500 which willcause some movement detectable by the motion sensor 210 on monitor 200.This will cause a monitor 200 to wake up 510, and begin to sense motionwith motion sensor 210 to determine whether motion typical of inhaler100 use has occurred. For example, herein are discussed various types ofinhalers 100 and the associated motions that are characteristic of orrequired for use with each type. In one example, an MDI inhaler 100 isshaken immediately prior to use. Other examples of this detection willbe discussed in more detail herein. Although these motions indicate thatuse is likely imminent, it is possible that the inhaler 100 might beshaken or moved in a certain way that is not due to use of the inhaler100. For example, the user may shake a rescue inhaler 100 but thendetermine it is not needed. Additionally, the inhaler 100 may beaccidentally shaken by movement from carrying or other activities in away that is characteristic of use by coincidence. Without furthervalidation, detection of only motion to validate usage may result in asignificant number of false positives.

Accordingly, in order to validate that use has occurred, the monitor 200may additionally sense other environmental characteristics indicative ofusage, such as temperature changes. For example, if motion is detectedthe monitor 200 may additionally activate the thermal sensors todetermine whether a temperature increase characteristic of a userapplying their mouth to a mouthpiece 110, or exhaling and inhaling. Forexample, experimental data has shown the there is a characteristicincrease and decrease in temperature during exhalation and inhalationnear an infrared temperature sensor aimed at the mouth. Accordingly, analgorithm can analyze the temperature data to determine whether anincrease and decrease typical of exhalation followed by inhalation isrecorded, or if there is a decrease in temperature in the case ofinhalation alone. This can include certain low pass filters, otherfrequency filters, and certain temperature increases or decreases withina prescribed amount of time of the motion. This can provide additionalverification that the patient has used the inhaler 100 as a user isunlikely to put their mouth near the mouthpiece 110 without intending onusing the device. Additionally, the sequence may also be a requirementto confirm usage. For example, the monitor 200 may require that thetemperature change be recorded after the motion indicating usage.

A temperature increase near the mouthpiece 110 alone may not provide areliable indicator of usage as the temperature may increase due to themouthpiece 110 being in close proximity to other sources of heat.Additionally, if the motion sensor 210 does not detect the prescribedshaking motion for an MDI inhaler 100 but detects a mouthpiece 110temperature increase, it may indicate suboptimal or failed usage. Inthat instance, the monitor 200 may provide a notification to the patientor to an associated processor or data storage medium that usage may nothave been optimal. Accordingly, data may be collected that indicates thequality of compliance in addition to the quantity.

Alternatively, in the case of the MDI inhaler 100, the monitor 200senses the temperature of the cartridge 105 to determine whether atemperature decrease characteristic of an MDI inhaler 100 being actuatedhas occurred. As discussed above, a temperature decrease detected for anMDI inhaler 100 without the prescribed shaking that occurred prior tothe decrease may indicate suboptimal usage. Additionally, the monitor200 may log the amount of time between the shaking of the inhaler 100and the temperature decrease of the cartridge 105. This may be importantto determine optimal usage as the inhaler 105 typically must be actuatedimmediately after shaking. This is due to the fact that the propellantsand medications immediately begin to stratify and separate due to theirdifferent densities inside an MDI inhaler 100. Therefore, to ensureaccurate and uniform dosages the inhaler 100 typically must be actuatedimmediately after shaking Overtime, improper usage through delayedactuation after shaking may result in a patient administering incorrectdosages. Accordingly, notifications may request the patient actuate theinhaler 100 quicker, or be sent to a health care provider forinstructions.

If after a certain amount of time has passed after motion indicatingusage is detected, a temperature change characteristic of usage does notadditionally occur, the monitor may not record usage 525. This can helpeliminate additional false positives created by accidental movement thatis characteristic of usage and temperature changes that arecharacteristic of usage. In some embodiments, the time window may be 30seconds, 10 seconds, one minute, a few minutes or other suitable timewindows. In some embodiments, the monitor will not validate the usagebased on a sequence. Rather, the monitor 200 will validate usage basedon expected motion and temperature changes that are close in proximitybut not necessarily in a specific sequence. Once the monitor 200 hasvalidated that a use has occurred through, for example, motion andtemperature changes, the monitor 200 records a usage 525. The date 560,time 555, location 565, humidity 550, temperature 540, and otherenvironmental factors may be recorded and associated with the datarepresenting that usage.

The monitor 200 may record that data based on internal clocks andmonitors, including GPS capabilities or the monitor 200 may immediatelysend the usage information to a mobile application 300. Alternatively,an internal clock may date and time stamp a usage and store the usage ina memory in communication for the monitor 200. Then, once a wirelessconnection is established between the monitor 200 and the mobile device150 the usage data may be downloaded to the application 300.Additionally, using the date 560 and time 540 information alreadyassociated with the usage by a monitor 200, an application 300 mayassociate additional information with that usage obtained from thirdparty sources.

In some embodiments, environmental data associated with the date 560 andor time 555 of usage in a specific location may be obtained through anAPI or other interface with weather provider's servers and databases. Inanother example, weather information may be determined from onboard orambient temperature sensors 220, humidity sensors, and other sensors.This information associated with the usage may provide important cluesconcerning a patient's susceptibility to triggering asthma reactionsbased on certain environmental factors.

In some embodiments, the motion detection step 520 may be replaced withmonitors of other characteristics indicative of usage. For example, inthe case of the MDI inhaler 100, if the monitor is position on the mainbody 140 and is therefore covered except during usage, the monitor 100may detect light changes. Accordingly, when a patient slides the mainbody 140 into usage position by pressing on MDI thumb pad 135, themonitor 200 can detect the increase in light and indicate use is likelyto occur. In some embodiments, the monitor 200 can monitor the light andremind the patient to close the cover 125 once usage has completed.

The temperature sensor validation step may be supplemented and/orreplaced with validation from sensors of other characteristics that areindicative of a usage. For example, a humidity sensor 550 located inclose proximity to a mouthpiece 110 may determine that the mouth is inclose proximity based on the increased humidity from exhaled air.Additionally or alternatively, capacitance may be used to validateusage, especially for embodiments in which the mouthpiece 110 is coveredexcept during usage, as is the case for the DPI disc inhaler 100. Insome embodiments, the cover 125 may enclose the monitor 200 exceptduring usage, protecting it from accidental contact with the capacitancesensor. Additionally or alternatively, a monitor 200 may include a colorsensor that can validate usage by confirming the sensor recorded a colorhue combination that is representative of a user's mouth or face. Thiscolor may be adapted to a particular user's color hue, thus eliminatingfalse positives for third parties that may use the device or when theinhaler 100 comes into contact with colors or areas of the body, such asthe hands, that are not indicative of usage.

Also, a distance or proximity sensor located on the monitor 200 maydetermine whether the patient's mouth or face approaches the mouthpiece110. The proximity sensor can be aimed outward from the mouthpiece 110and determine whether an object came close an inhaler after recordingmotion. Additionally, a proximity sensor may be utilized in conjunctionwith a temperature sensor 225 to confirm an object (i.e., the mouth)came within close proximity to the mouthpiece 110 during the requisitetemperature changes. A proximity sensor may be any suitable proximitysensor including a laser, infrared, and an active sensor including sonaror active sensing lasers, or others.

In some embodiments, a monitor 200 may also validate usage in place ofthe temperature validation step 540 or the motion sensing step 520, bymonitoring the sound for characteristics indicative of usage. Forexample, the temperature validation step 540 may be replaced orsupplemented by monitoring the sound, for example by listening forsounds indicative of a strong inhalation typical of inhaler 100 use.Additionally, the audio sensor 215 may listen for sounds indicative thatthe inhaler is actuated or being primed for actuation. For example, theMDI inhaler 100 may emit a distinct sound during actuation and sprayingof the aerosol. Additionally or alternatively, the DPI inhaler 100 mayemit distinct clicking sounds when the cover 125 is rotated to uncoverthe main body 140 or the lever 130 is actuated into place. Additionallyor alternatively, a compressor or other motive element of a nebulizerinhaler 100 likely will have a loud and distinct sound that may bemonitored by a monitor 200.

Other factors other than temperature can be utilized to validate usage.For example, a distance or proximity sensor located on the monitor 200may determine whether the patient's mouth or face approaches themouthpiece 110. The proximity sensor can be aimed outward from themouthpiece 110 and determine whether an object came close an inhalerafter recording motion. Additionally, a proximity sensor may be utilizedin conjunction with a temperature sensor 225 to confirm an object (i.e.,the mouth) came within close proximity to the mouthpiece 110 during therequisite temperature changes. A proximity sensor may be any suitableproximity sensor including a laser, infrared, and an active sensorincluding sonar or active sensing lasers, or others.

In some embodiments, a monitor 200 on the nebulizer inhaler 100 may beattached to the mouthpiece 110, and implement a two-step validationprocess. This process may include monitoring audio data for soundsindicating the compressor or motive element is operational and sensingtemperature 530 or other changes indicative that the patient's mouth isnear the mouthpiece 110. In some embodiments, the audio validation mayreplace both the temperature 540 and motion validation steps 520, orsupplement them in various combinations to decrease the probability offalse positives. For example, in the case of the MDI inhaler 100, theaudio monitor may detect the clicking indicative of priming the inhaler100 for use, and then detect the breathing sounds confirming usage hasoccurred.

For each the environmental characteristics monitored mentioned above,they may be all monitored to increase the confidence of usagevalidation, or certain sub-combinations and sequences indicative of usemay be utilized to validate usage. Accordingly, the embodimentsdescribed are only given as examples, and in no way intended to limitthe various combinations that may be implemented by one of skill in theart to validate usage.

For each type of inhaler 100, the environmental factors or process forevaluating monitored data to confirm usage may vary based on the type ofinhaler 100 or may be the same. Additionally, these techniques may beapplied to other types of inhalers 100 not specifically disclosedherein. Below, some examples of the logic and algorithms implemented toconfirm usage for each type of monitor 200 are disclosed.

Monitoring Compliance—MDI Inhaler Examples

For proper usage, an MDI inhaler 100 may require a user to shake theinhaler 100, bring the inhaler 100 to a patient's mouth, depress theinhaler 100 to actuate, and breathe in the aerosolized medication.Therefore, these steps prescribed for proper use may be used to validateusage based on the methods described above.

For example, once a patient picks up the MDI inhaler 500, the monitor200 may wake up and begin to monitor motion for movements indicative ofuse. The motion a patient is instructed to perform is generally ashaking motion, wherein the MDI inhaler 100 is moved back and forth ingenerally the same axis or nearly the same axis. The motion sensor 210may monitor this motion and output data to be analyzed by a controller235 to determine whether the motion recorded is indicative of use 520.

Many different algorithms may be implemented for determining whether theshaking motion prescribed for use of an MDI inhaler 100 has occurred.For example, the shaking motion will generally occur along one axis, andvarious components of the motion may be analyzed to confirm this. Insome embodiments, an accelerometer (or magnetometer or gyroscope) maymonitor motion data for sudden changes in acceleration that occur in apositive, negative, positive sequence in substantially the same axis orplane. In some embodiments, an acceleration switch oriented in the axisof motion may be utilized to determine acceleration that crosses acertain threshold.

Additionally, the shaking motion of an MDI inhaler 100 generally willreach a threshold velocity and acceleration. For example, testing hasrevealed that typical shaking motion generally reaches an accelerationthat is 1-2 times the acceleration of gravity. Therefore, the processingof motion data to determine whether it indicates use 520 may incorporatea threshold filter. In some embodiments, this threshold may be equal tothe acceleration of gravity, 0.5 times the acceleration of gravity, 0.3times the acceleration of gravity or other suitable thresholds. Applyinga threshold hold filter will likely eliminate false positives due to theinhaler 100 experiencing small accelerations during normal activitiesthe patient may engage in while carrying an inhaler 100. Additionally,an acceleration switch or a plurality of acceleration switches may beused a low cost and low power consumption option to determine if andwhen acceleration in certain axes crosses a certain threshold. Thesecould be used to look for a certain pattern in detecting accelerationabove a threshold, for example, in the same axis but in a negative,positive, negative sequence.

The shaking motion recorded by a monitor 200 for an MDI inhaler 100 mayalso exhibit certain frequencies not achieved by other common activitiesa patient may engage in. Testing has revealed that the shaking motiongenerally reaches a frequency 3-6 Hz. Accordingly, a frequency filter orother devices or techniques known in the art for evaluating thefrequency of the motion may be implemented to determine whether motionindicative of use has been detected 520. This may include a notch orband-pass filter. This frequency band may be 3-6 Hz, 2-7 Hz, 4-7 Hz, orother suitable frequency bands. In other embodiments, the frequencyfilter may only filter out frequencies lower than a threshold frequencyof 2, 3 or 4 Hz, or other suitable thresholds.

Additionally, the step of determining whether the motion indicates use520 may record the length of time for which the inhaler experience acertain magnitude, frequency or acceleration. Accordingly, if afrequency pattern is experienced for a length of time that is longerthan a patient would typically shake an inhaler, the monitor maydetermine that no use should be recorded 525. This period of time may bea few seconds, or up to thirty seconds or a minute, or other suitabletime periods.

Each of these above-mentioned features of the motion that may bemonitored can be utilized in the step for determining whether the motionindicates use 520 alone or in various combinations. For example, a bandpass frequency filter may be utilized to first detect motion of acertain frequency, followed by a filter that determines whether thefrequency reaches a minimum magnitude. Additionally, the analysis stepmay determine whether the acceleration occurs in the back and forthpositive and negative pattern for a certain number of iterations. Thiswill likely eliminate false positives from activities such as running,riding in vehicles, or other activities that have significant butsustained acceleration patterns.

After the motion is monitored and analyzed, various othercharacteristics of MDI inhaler 100 usage may be monitored to confirmusage. For example, the temperature of the cartridge 105 of the MDIinhaler 100 may be monitored 530 to determine whether the cartridge hasbeen actuated 540. In some embodiments, the monitor 200 may monitor theambient temperature 535 as well, and compare the ambient temperature tothe cartridge 105 temperature to validate usage 540. The temperature ofthe cartridge 105 may be monitored with any suitable temperaturemonitor, including a probe, thermistor, infra-red monitor, or any othersuitable monitor.

In another example, the monitor 200 may monitor the temperature in closeproximity to the mouthpiece 110 to determine whether an increase intemperature characteristic of an open mouth is detected. For example,the monitor 200 may monitor the infra-red signature 530 directly infront of the mouthpiece 110. This method can be advantageous because apatient typically is not instructed to touch their mouth to themouthpiece 110 to avoid contamination and bacteria growth. Therefore,the infra-red temperature sensor 225 may be aimed in a position fordetecting an open mouth in the location the mouth would likely occupyduring usage. The monitor for temperature 530 may also determine thelength of time that the temperature increases. A temperature increasethat persists for longer than a few seconds may likely indicate thatusage has not occurred, and that the inhaler 100 has been moved to awarmer environment. In some embodiments, the monitor 200 may alsomonitor the ambient temperature 535 and compare the two readings andonly confirm usage when the infra-red or mouthpiece 110 temperature hasrisen with respect to the detected ambient temperature 535. Accordingly,this can help eliminate false positives that may occur by the inhaler100 being relocated to an environment with a warmer temperature.

Monitoring Compliance—DPI Inhaler Examples

In another example, a DPI inhaler 100 may require the user to hold theinhaler level with respect to the ground, push on the thumb pad 135 toreveal the lever 130 and mouthpiece 110. Next, the patient typicallymust slide the lever 130 to prepare the powdered dosage for inhaling,bring the inhaler mouthpiece 110 to the patient's mouth, and deeplyinhale the prescribed dosage. Therefore, these steps prescribed forproper use may be utilized to validate usage based on the methodsdescribed above.

For example, once the monitor 200 wakes up 510, the monitor 200 mayevaluate the motion 520 to determine whether the inhaler 100 is level orhorizontal relative to gravity. A skilled artisan may implement amultitude of algorithms to perform this function. For example, a motionsensor 210 may output the orientation of the monitor 200 andaccordingly, the inhaler 100. Therefore, the motion data may be analyzedto determine whether the inhaler 100 is picked up and held betweencertain angles with respect to gravity. A skilled artisan may design themonitor to sense when the angle is within plus or minus 3, 4, 5, 10, 15,20, 30 or even 40 degrees deviation from being level or horizontal withrespect to gravity. The algorithm may also determine whether the deviceis held within that range for a specific time interval, for example, 3,5, 7, 10 seconds or other time periods. Additionally, an algorithm mayalso distinguish between the monitor 200 resting on a flat surface in abuilding or outside (not moving in a vehicle) by determining no useshould be recorded 525 when the acceleration is virtually non-existent.Accordingly, when a patient is holding an inhaler still, the patientwill not be able to keep the inhaler 100 absolutely still and themonitor 200 will be able to distinguish between these two situations.However, confirming the inhaler 100 is held level for a predeterminedperiod of time may allow for a significant number of false positives,and therefore additional environmental characteristic confirmation maybe included.

In some cases, patients are instructed to hold DPI inhalers 100initially vertically during actuation of the lever 130 and then rotatethe inhaler 90 degrees towards the mouth to inhale. In this case, themotion evaluation algorithm may be based on determining if the inhaler100 is held vertically for a threshold window of time, and then rotatedthrough a certain degree range towards a horizontal orientation.Additionally, an algorithm may evaluate the motion sensor 210 outputdata for other characteristics of this motion including angularacceleration.

The controller 235 and associated modules or other associated processorsand software may evaluate the motion sensor 210 output data to determinewhether a movement signature of sliding the main body 140 by pressingthe MDI thumb pad 135 is detected. Next, the motion sensor 210 canprocess the signal to determine whether the signature of the sliding thelever 130 is detected. Both of these motions may have similarsignatures.

In some embodiments, the monitor 200 may be clipped into the lever 130in order to sense when the lever 130 is being moved. The characteristicsof the relevant movement in this example can be a short accelerationfollowed by an abrupt acceleration in the opposite direction once thelever 130 clicks to a stop. Additionally, after the lever 130 isactuated a patient typically brings the DPI inhaler towards the mouth toinhale the medication. The sensor 200 may accordingly sense theacceleration followed by deceleration associated with this motion,according to certain time constraints. For example, an algorithm mayanalyze motion data output from the motion sensor 210 to determine if anacceleration and deceleration within the same axis, or substantially thesame axis, is experienced within a time window. The time window may be afew seconds or more, or may not be required at all.

Next, after sensing a motion or combination of motions that indicateusage is likely, 520, the monitor 200 may begin to monitor othercharacteristics to confirm usage. For instance, a monitor 200 connectedto a DPI inhaler 100 may sense a temperature in close proximity to themouthpiece 110 of the MDI inhaler 530. In some embodiments, this mayinclude an infra-red sensor 226 that monitors for changes in temperaturethat are indicative of an open mouth near the mouthpiece 110. Thealgorithm and logic for monitoring the oral temperature changes may beanalogous to those described herein and for the MDI inhaler 100.

As described above, additional environmental characteristics may besensed in order to confirm that usage has occurred. For example, if amonitor 200 is placed on the main body 140 of the DPI inhaler 100, alight monitor may detect when the main body 140 has been rotated toreveal the mouthpiece 110, lever 130 and monitor 200. The light sensorand associated controller 235 may use a simple algorithm that detects athreshold level of light indicative of removing the cover 125.

Additionally, a monitor 200 may monitor ambient sound to detect certainevents surrounding usage of a DPI inhaler 100. For example, a patient'ssliding of the cover 125 using the thumb pad 135 and actuation with thelever 130 create audible short clicks. Therefore, once the monitor 200is awake due to movement, the light monitor, or other wake up events, itmay monitor ambient sound to determine whether a click is detected. Insome embodiments, the analog sound detected may be converted to digitaldata by an analog-to-digital converter. Next, the audio data may befiltered for noise, by removing unwanted frequencies by methodsdiscussed herein in connection with motion processing. Additionally, thefiltered audio data may be analyzed to determine whether it isindicative of the clicking noises associating with preparing the DPIinhaler 100 for usage. As these are examples only, additionalenvironmental characteristics may be monitored for confirming usageincluding those discussed herein.

Monitoring Compliance—Nebulizer Inhaler Examples

To properly operate a nebulizer inhaler 100, a patient may perform aspecific series of actions that have qualities detectable by a monitor200. For example, a patient may fill a reservoir with medication, turnon the powered element (e.g., compressor, piezoelectric), and put on themask or put the mouthpiece 110 near or into the patient's mouth. Next,the patient may breathe in the medication aerosol formed by theelectronic motive element. Therefore, these steps prescribed for properuse may be utilized to validate usage based on the methods describedabove.

In some embodiments, the patient's picking up the mask or mouthpiece 110associated with the nebulizer inhaler 100 may wake up 510 the monitor200. Next, a monitor 200 may begin to monitor the motion 515 with motionsensor 210. The controller 235 may then evaluate the motion data outputfrom the motion sensor 210 using algorithms to determine whether thedetected motion data indicates usage has occurred. For example, themotion created by the compressor or piezoelectric component associatedwith the nebulizer inhaler 100 may have a distinct and periodicvibration. For example, the vibration motion may have a frequency thatfar exceeds other motion experienced by the monitor 200. Additionally,as discussed herein, other algorithms may be applied to the motion datathat apply threshold magnitudes for the vibration detected to eliminateother vibration from motors or other devices that may be further awayfrom the compressor.

Additionally, in some embodiments, once the device wakes up 510, it mayestablish a baseline data level, and then monitor the motion data todetermine whether a sudden new frequency component is introduced. Thatway, if the inhaler or nebulizer 100 is being used in a hospitalenvironment, which likely contains a plethora of other devicessurrounding a patient, the noise will be used as a baseline before thecompressor is switched on. Furthermore, the monitor 200 (or a relatedsystem) may also require the vibration from the motor of the compressorfor a predetermined period of time before registering usage.

Next, if the monitor 200 determines that the detected motion indicatesusage is likely, for example, by sensing the compressor is switched on,the monitor 200 may evaluate additional characteristics to confirmusage. Additional confirmation may help prevent false positivespotentially created by a patient switching on a compressor but notbreathing in the medication, or a neighboring patient switching on adifferent nebulizer inhaler 100. One additional characteristic that maybe monitored is temperature changes that are indicative that a patienthas applied their mouth to the mouthpiece 110 or mask.

The monitor 200 controller 235 may then activate the various temperaturemonitors that may be incorporated with the monitor 200. For example, themonitor 200 may activate the ambient temperature monitor 535, and theoral temperature sensor 225. The controller 235 may evaluate the dataoutput from these sensors to determine whether the difference indicatesa patient's mouth has been placed near the mouthpiece 110. For example,an infra-red monitor 225 may be positioned near the mouthpiece 110 andaimed in a position to detect an open mouth.

If the temperature change is recorded that indicates use is likely 540,then the monitor 200 may record the usage 545 as discussed herein.Additional factors may be monitor instead of or in addition to thosedescribed herein to confirm a patient has used a nebulizer inhaler 100.For example, the electromagnetism created by the compressor may besensed. Additionally, the monitor 200 may monitor sound to confirmusage. As discussed above, the compressor or piezoelectric may createdistinctive motion and sound waves detectable by an audio sensor 215connected to a monitor 200. These may be analyzed through audio analysistechniques known in the art and discussed herein. Additionally, thesemay be used in place of the motion sensing or as additional confirmationof usage.

Also, monitor 200 controller 235 may not require the motion andtemperature to be detected in a sequence. For example, instead of asequence, a monitor 200 may only detect a combination of the motion andcharacteristic temperature change to indicate usage. Other combinationsand sequences may also be utilized.

Assisting a Patient with Compliance

FIG. 13 illustrates an example of a process and method through whichusage data received may be processed and implemented to assist a patientwith asthma inhaler compliance and other advantages. This process may beimplemented by an application 300 or other module installed on a mobiledevice 100, a server 700, available over a network 400, or others. FIG.13 provides only an example of a method that may be implemented forassisting patient compliance, and therefore the available methods forassisting patient compliance should not be limited to those illustrated.

In one example of a method for assisting a patient in managingcompliance, once the system 280 receives confirmation data that usagehas occurred, the system 280 may request that a patient confirm the typeof inhaler used or other characteristics of the symptoms or usage. Asdiscussed, inhalers medications are available in at least two differenttypes: daily preventative anti-inflammatories, and rescue medicationswith bronchodilators (rescue medication are available in differentdosages, including smaller dosage inhalers for patients in a situationwhere rescue is anticipated). If a patient has more than one medicationtype available, but utilizes the same monitor, the system 280 may needto determine which inhaler has been utilized. For example, anotification may pop up on a patient's mobile device that asks whetherthe medication used was daily preventive or a rescue medication. Oncepatient responds and selects which medication has been utilized, thattype of medication may then be associated with that usage data.

In some embodiments, each inhaler 100 medication type will have its ownmonitor 200 and therefore, confirmation of the type of medication willbe unnecessary. Inhalers 100 may also include several different types ofmedication. For example, a 3-in-1 inhaler 100 may including a rescue, asneeded, and scheduled medication as disclosed herein. In someembodiments, the inhaler may allow each of the medications to be rotatedinto place for actuation, or oriented with a certain medication beinglevel or in a position for use by the patient 710. In some embodiments,the concepts discussed above with respect to motion sensing may beapplied to determine which medication has been used by a patient.

The system 280 may request a patient confirm other informationassociated with usage, including whether asthma symptoms decrease aftermedication, periodic questionnaires regarding symptoms, questionsregarding severity of attack if rescue medication is used, and otherdata. Once the data is entered from the patient, or the usage data hasbeen downloaded, the system 280 may then store and analyze the data andcompile the total number of uses. Thus, each uses is added to a total545 usage and further utilized to provide compliance assistance to apatient.

For example, the system 280 may include a dosage counter that monitorsthe capacity 625 indicating the number of remaining dosages left in thecartridge 100 or inhaler 100. For example, the total uses remaining foreach type of inhaler 100 the patient owns may be recorded and output toa display 260. The display 260 may be as part of an application 300 oraccessible via a health care provider's servers, or on a monitor 200.Additionally, the system 280 may continually check to determine whethera refill is warranted 645. The number of dosages in a particular type ofcartridge 105 may be determined in advance by a health care provider, ormay be calculated by experience with a particular inhaler for aparticular patient. For example, the system 280 may use an estimate ofthe number of dosages the first time a patient uses a particular type ofinhaler cartridge 105. However, once the patient uses the new type ofinhaler until empty, the usage data will allow the system 280 todetermine the number dosages that type of inhaler typically willinclude. This data may be modified over time with additional usage bythe patient. The capacity of the inhaler 100 may be displayed as adosage number remaining, a capacity amount remaining, an estimatedlength of time until a refill is required and other suitable metrics.

The system 280 may also send a notification to the patient through anapplication 300, for example a pop-up notification on a mobile device,that the capacity is low. Additionally, the system may have an optionfor the patient to click and directly order a refill cartridge 650 asdiscussed in detail herein. This notification may be sent when thecapacity is at 15%, 30%, or a fixed number of uses. Additionally,depending on the anticipated or experienced lag time in replacementdelivery, the notification may calculated to pop-up sufficiently inadvance to allow delivery of a refill before the cartridge isanticipated to become empty.

The system 280 may include processes for monitoring and assisting withcompliance 630. These processes may include methods for notifying apatient when a daily dosage is due, for locating an inhaler 100, forwarning a patient they have entered a situation that may potentiallytrigger an asthma attack. For example, the system for monitoringcompliance 630 may include a process for determining when the nextdosage should be taken, based on a patient's dosage regimen and priorusage history. In some embodiments, this may include determining a timefor a next use 660 based on previous usage or determining fixed timesduring the day that the patient should be reminded to use themedication. If the system 280 determines a new medication dosage shouldbe taken, a notification is sent to the patient 670. This may be anotification on an application 300, or an alert initiating on theinhaler 100 or both.

The system 280 may include a feedback system that assists a patient intiming of inhalation. For example, an MDI inhaler 100 requires a certaintiming of inhalation and exhalation to properly absorb the aerosolizedmedication. As patients are instructed to keep their mouth close but notcovering the mouthpiece 110, once they actuate the MDI inhaler theaerosolized medication is released on a cloud outside the mouthpiece110. At the right moment the patient must inhale the cloud of medicationbefore it disperses. Additionally, a patient must hold the medication inits lungs for a set time period before exhaling again, or else themedication will not be properly absorbed.

A feedback system may thus be implemented to assist a patient with theproper timing of inhalation and exhalation. For example, after a patientactuates the inhaler 100, a display 260, or other indicator may indicateto the patient the appropriate time to inhale, the appropriate amount oftime to hold the medication in the patient's lungs, and the appropriatetime to exhale. A color coded system could be used for such purpose. Forexample, a green light may indicate a patient should inhale themedication, a yellow light indicate the patient should hold, and aswitch back to green may indicate the patient is free to exhale themedication. Any other color scheme, audio indications, or otherindications may be used to provide the feedback. Additionally, thefeedback may be provided by the monitor 200, an application installed onan associated mobile device 150 or other associated device.

The system for monitoring compliance may also include a locate inhalerfunction 665. This process may be initiated in response to the systemdetermining it is time for a patient's next use, or manually by thepatient requesting the function be initiated through the application 300on their mobile device 150. The locate inhaler function 665 may indicatethe distance to the inhaler 675 from a mobile device 150 running anapplication 300 interfaced with the monitor 200. This may be provided bywarning the user when the mobile device is moving closer to or away fromthe patient. This may be done by the strength of the Bluetooth signal orby separate GPS devices on the monitor 200 and mobile device 150.

The locate inhaler function 665 may also send a notification to themonitor 200 to flash a visual or initiate an audio alert 685, or beginto vibrate. This will allow the user to identify the inhaler more easilyidentify and locate the inhaler.

Health Care Provider Information Network

FIG. 14 is an overview of an example interface of the overall asthmacompliance assistance system 280, in communication with a health careprovider's information network. An application 300 on a mobile device150 may have a wireless 250 or wired link to a network 400 in order tobe connected to the services of a health care provider utilizing anasthma compliance system 280. Network 400 is a broad term and mayinclude, without limitation, the internet, virtual private networks,local area networks, wireless local area networks, wide area networks,metropolitan area networks, and personal area networks. The provider mayhave a server 700 that may be accessed over a network 400 through awebsite or other appropriate interface by a patient 710 or parents of apatient 710, or by a doctor or other health care providers 715.

The server 700 may provide usage statistics, compliance information andother features discussed herein to the patient 710 or health careprovider 715. This will allow the patient 710, the patient's doctor, andothers to evaluate the compliance and usage data to recommendmodifications in dosages or provide feedback and encouragement regardingusage. Additionally, health insurance providers 715 may also access theinformation to give rate discounts on premiums or other incentives topromote compliance by a patient 710.

The asthma compliance system provider may include servers that operatethe provider services 710 and associated computers and software thatexecute features discussed herein and additional features. The providerservices 720 may be accessible over networks 400 including the internetand may be in communication with a patient's 710 mobile device 150. Forinstance, as information is collected from the monitor 200 and uploadedto the mobile device 150, it may be uploaded to the provider services720 systems and processed for further utilization. Additionally,notifications, new firmware, software, or other information may be sentdirectly from the provider services 720 systems to the patient'sapplication 300 on their mobile device 150. Accordingly, notificationsmay then be sent wirelessly to the patient's monitor 200 connected tothe asthma inhaler 100, or new software or algorithms may be downloaded.These instructions may be for a new type of inhaler 100, for a change inpatient treatment regimen, or for other appropriate situations.

The provider network may include a database 705 for storing informationcollected from monitors 200 from various patients 710 and from othersources including weather information, and manually entered data. Thisdatabase may be accessed by provider services and also by the patient710 through the server 700.

Cartridge Refill Provider

FIG. 15 illustrates an example of the network connectivity between apatient and a refill cartridge supplier 730 that allows a patient topurchase refills through their mobile device 150. Once the system 280determines a refill is needed 645, that information may be sent to asupplier 730 over a network 400 through a variety of channels.

FIG. 15 illustrates one example of such connectivity. A supplier's API725 may be utilized to integrate the provider's services 720 with thepatient's application 300. Accordingly, the supplier 730 may be notifieddirectly that a refill is required or purchased by integrating itspurchasing, billing, and shipping information systems, with thepatient's application 300. Accordingly, once the patient confirms he orshe would like to purchase an additional refill, that information andconfirmation may be sent back to supplier 730 through an API 725. Thus,the transaction may be performed securely and conveniently without,human interaction on the provider side. In another embodiment, thenotification may be sent to supplier 730, but the order filled manuallyby the supplier 730 once the data is received.

FIG. 16 illustrates an example of a step-by-step sequence for orderingand sending a refill. First, an asthma compliance system 280 maydetermine that a refill is required soon 800. Next, a notification maybe sent to a patient notifying them that a refill is required 650. Thepatient 710 may also optionally be presented with an option to directlypurchase a refill 805. The patient may confirm this and purchase therefill 810 by accepting or clicking purchase on their mobile device 150or other computer used to interact with the system 280. Next, thepurchase notification is sent to the supplier API 815, which translatesthe information into a purchase order or electronic request to purchasean inhaler refill. Then, the supplier's systems may confirm and processthe order 820, and send it to the patient 825.

Neural Network for Predicting Asthma Symptoms

FIG. 17 illustrates an example of a neural network 915 implemented toaugment the compliance and asthma management system 280. Generally, theneural network 915 may utilize data from many different users 900 of theasthma management system 280, including their personal attributes andenvironment, and utilize that information to make predictions abouttriggers and treatments for individual patients 710. Thus, the neuralnetwork 915 may assist in predicting the environmental factors that maytrigger the onset of an asthmatic reaction in a patient 710.Additionally, the neural network 710 may be implemented to modify apatient's daily medication regimen to improve its efficacy or costeffectiveness.

FIG. 17 illustrates one example of the connectivity of the system thatmay be utilized to implement a neural network 915. A health careprovider may provide an asthma compliance system 280 as disclosed hereinto several users 900 or clients. Accordingly, usage data 600, personalinformation, and medical histories related to those users 900 may bedownloaded over a network 400 aggregated and processed by the providerservices 720. Additionally, this data may be stored in the database 705.Thus, the system 280 may aggregate large amounts of data, about theplaces, environments, and factors that trigger asthma attacks and theeffect that certain dosage regimens have on specific patients.

This data may be very useful as a predictive indicator for how likepatients may respond to similar environments, treatment regimens, andwhat may trigger attacks in specific patients 710. Accordingly, thepredictions may be sent to patients as warnings for attacks, asrecommendations for doctors to evaluate and modify a treatment regimen,and as information as when a patient 710 may take increased dosages ofpreventive medication.

Below is an example of how a neural network may provide assistiveinformation and notifications to a patient 710. When a patient enrollsin an asthma compliance system 280, they may fill out a personalquestionnaire, or allow their personal information and medical historyto be loaded into the database 705 via the provider services 720 orother sources. Additionally, over time, the usage data 600 collected bythe system 280 may be aggregated by the provider services 720 and storedin the database 705. Additionally, other users 900 may accumulate usagedata 600 and upload that information to the provider services 720 alongwith their personal information, medical histories, and genetic makeup.

This information may be processed by a neural network 915 that is incommunication with provider services 720. The neural network 915 maydetermine patterns including factors for certain patients that produceasthma attacks based on location, weather, medical histories, altitude,and genetics. Additionally, the neural network 915 may be able todetermine patterns that indicate frequencies of attacks based on dosageregimes and other effects of dosage regimens on certain patients.

Once the neural network 915 has established these patterns and the modelis created, the individual patent 710 usage data, personal medicalhistory, and genetics may be processed by the neural network 915.Accordingly, the neural network 915 may be able to modify the dosageregimen of the patient 710 to determine an optimal dosage or formulationfor a specific patient. Additionally, the neural network 915 may be ableto determine certain formulations with different by similar activeingredients that may provide the optimal treatment outcome.

Additionally, the patient's environmental details can be continually fedinto the neural network 915 and the neural network 915 may predict thatthere is a high likelihood that the patient's present environment maytrigger an asthma attack. For example, a patient may be traveling to anew state, for example Nebraska. Once the patient arrives at thedestination, the patient's cellphone may send location data to theapplication 300 which is then transmitted over the network 400 to theprovider services 720 and processed by the neural network 915.Accordingly, the neural network 915 may then determine that an asthmaattack is likely because similar patients experienced such attacks inNebraska (or under similar conditions to those now present in Nebraska,as determined by the neural network). Accordingly, the provider services720 may send the alert notification 910 data over the network related tothe warning to be transmitted to the application 300. The application300 may then pop up an alert notification 920 to the patient 710 thatindicates the patient 710 should have the rescue medication ready orshould take preventative medication.

Additionally, the neural network 915 may prepare reports that indicatehigh risk factors for a specific patient 710. The patient 710 may accessthe reports through the application 300 on his or her mobile device 150or remotely over a network 400 through accessing a website interface forthe server 700. The report may include problematic areas of the countryor world that may trigger attacks.

Compliance Monitor Design—Universal Insert for Inhalers

FIGS. 15-16 illustrate examples of a universal monitor 200 that isconfigured to be removably connectable to a variety of inhalers 100. Theuniversal monitor 200 may be any shape or configuration that may beconnected to a sensor 200 housing. For example, the universal monitor200 may be a small cylindrical or square shape that is configured toattach to a space, or opening in a monitor 200 housing. FIG. 18illustrates an example of a monitor housing designed for an MDI inhaler100 that is configured to be connectable to a universal monitor 200.FIG. 19 illustrates a similar embodiment for a DPI inhaler 100. As shownby the dashed arrows between the sensors 200 and the inhalers 100 ofFIGS. 18 and 19, in some embodiments, the universal monitor 200 may pluginto, or snap on the outside of a monitor 200 housing. The universalmonitor 200 may connect to the monitor 200 housing by any other suitablemeans. The universal monitor 200 may contain the majority or all of theelectronic components of the part of the monitoring system 280 that isphysically connected to the inhaler 100. In other embodiments, theuniversal monitor 200 may contain a portion of the electroniccomponents.

Accordingly, the universal monitor 200 may be removed from one inhaler100 and applied to another inhaler type (e.g., MDI to DPI).Additionally, a manufacturer will be able to fabricate a singleuniversal monitor 200 for the variety of sensor types, eliminatinginefficiencies created by requiring the process, boards, or othercomponents to be separately incorporated into each type of housing 110for each type of inhaler 100.

Multiple Criteria, Sensor Verification

FIG. 20 illustrates schematically how one or more sensors can confirm1208 that one or more criteria (1201, 1203, 1205) have been completed1207. For example, a system may have a goal of completing 1207 a seriesof criteria (1201, 1203, 1205) in sequence or in parallel. Thesecriteria can be physical acts or otherwise measurable events. Sensors(1202, 1204, 1206) can be designed, configured, positioned, etc. tomeasure or record (1212, 1223, 1225, 1243, 1245, 1265) the criteria orbyproducts related to the criteria. An elegant system can use a singlesensor to confirm more than one criterion. For example, sensor 1 (1202)may be used to confirm criterion 1 (1201), as indicated by arrow 1212,to confirm criterion 2 (1203) as indicated by arrow 1223, and to confirmcriterion 3 (1205), as indicated by arrow 1225. Such elegance can behighly desirable because it may save on manufacturing and/or operatingcosts.

However, in some cases, multiple sensors may be useful. For example, thecriteria may be so different that very different sensors are required tomeasure them. In some cases, a cheap sensor may be less expensive ormore energy efficient to operate, while a high resolution sensor may beable to gather data more effectively or more rapidly. In this case, itmay ultimately be more advantageous to trade physical elegance forenergy efficiency, because two sensors together can be more efficientthan a single sensor.

Some particularly useful embodiments of a monitor system incorporatethree sensors that can obtain data independently but work together inthe system. A first sensor can be a simple mechanical sensor, alsoreferred to as a switch, which can have very low power consumption. Thisfirst sensor can be relatively simple compared to other sensors byhaving fewer axes or dimensions that are sensitive to motion, byrequiring a threshold magnitude of motion before switching on, etc. Sucha sensor can act as a system switch to turn a controller, processor,and/or other sensors on and off, thereby saving energy. A second sensorcan be more sensitive and/or allow more types of data to be collected,although it may also have greater power consumption as a result of itsadditional capabilities. An example of a second sensor is a digital AGMsensor, such as those used in the aerospace industry. The second sensorcan measure the frequency of a shaking motion of an inhaler withsufficient accuracy to process the data and recognize a signature motionas described above. The third sensor can be a directional infraredsensor, for example. This third sensor can have its directional axisaligned with the opening of an inhaler that is configured to passinhalants into the mouth of a user. Thus, the sensor can taketemperature data indicating or confirming when the inhaler is positionedto provide a dose into the mouth of a user. Thus, in some three-sensormonitoring systems, a first sensor plays the role of aninitialization/power-saving switch, a second sensor plays the role ofhigh resolution motion sensor, and a third sensor plays the role ofconfirming sensor. The third sensor can be particularly helpful in itsconfirmation role if the data it takes is distinct from the data fromthe second sensor. Thus, a temperature sensor aimed at the place where amouth would be can be particularly helpful in confirming that a willful,pre-dosing shake has occurred and the user has indeed intended toperform the full dosing motions.

Another example of a series of criteria can be provided in the contextof a disk inhaler the disk inhaler and cover described above (see, e.g.,FIG. 4A, FIG. 4B, and/or FIG. 4H). The criteria can comprise one or moreof the following: (1) Open—opening the device, exposing the mouthpieceand the lever; (2) Click—pulling the lever back, dispensing themedication into the mouthpiece; (3) Inhale—placing the device on theuser's lips and inhaling the medication; (4) Close—closing the deviceand storing it in a dry place. Medication from a DPI is often takentwice a day, once every twelve hours. The above four criteria can, forexample, be confirmed using one or more sensors. One or more rotationsensors can be used to confirm criteria (1), (2), and/or (4); anaccelerometer can be used to confirm criteria (1), (2), and/or (4); asound sensor can be used to confirm criteria (1), (2), (3), and/or (4);a light sensor can be used to confirm criteria (1), (3), and/or (4); atemperature sensor can be used to confirm criterion (3), as well as thepresence of a hand that may be engaged in criteria (1)-(4); etc.

A nebulizer (see, e.g., FIG. 2E) can have a distinctive sound or motionwhen it is turned on. Steps involved in using a nebulizer can include:(A) open the cup (see, e.g., FIG. 2C) and place the medication inside,then close the cup; (B) connect the tubing 112 into the nebulizer andattach the mouthpiece 110; (C) turn the nebulizer on; (D) hold themouthpiece 110 to the user's mouth and have user breathe in using themouth, continuing to breathe in this manner until no medication remains.Nebulizers are often prescribed for use only during an asthma attack. Asensor or sensor system can be attached to the body of a nebulizer tomore readily detect distinctive vibrations. Nebulizers that produce adistinctive humming or buzzing sound can employ a sound sensor (e.g., amicrophone) to detect when they are in use to help monitor use.

Detection of MDI Inhaler Use

As noted above, a criterion for verifying that an MDI inhaler has beenused, for example, is for the user to shake the inhaler. Typically, theprescribed shaking motion will be distinctive relative to other motionsmade during most activity. Experiments were performed to verify this.The approach was to list expected motions for an inhaler to experienceand then comparing the acceleration data for these motions compared tothe shaking motion. By verifying the uniqueness of the shaking motion,the validity of the method of using an accelerometer to detect the useof an inhaler can be proven. Uncertainties in results from a singlesensor can be overcome by using other sensors (e.g., temperaturemeasurement, magnetometer and gyroscope measurement, etc.)

Motions tested included the following: prescribed inhaler shaking;walking; running; jumping; driving; biking; tossing the sensor.Positions for the sensor during testing included the following: hand,pocket, keychain, bag, purse, backpack, loose.

FIG. 21A shows data taken when an accelerometer is shaken in the waythat an inhaler would be shaken before use—that is, the prescribedshaking motion. The vertical axis on the graph is the acceleration ingravities. Acceleration in gravities (gs) is plotted versus time. Theaccelerometer has the ability to measure up to 2 gravities, which isclose to the maximum value of what it records during this motion. Thereis a regular back and forth motion that can be observed on all threeaxes, though the most dramatic motion appears to be on the y-axis of theaccelerometer (green) because this is the axis that corresponds to theup and down motion of the accelerometer.

FIG. 21B shows data from a longer period of time that includes the timedepicted in FIG. 21A, as shown. It also shows two other subsequent timeperiods 2120 during which prescribed shaking occurred. This dataindicates that the prescribed shaking motion does indeed result in adistinctive data pattern, and that this pattern can be defined orotherwise recognized as a signature motion for the purposes discussedherein.

FIG. 21C shows data gathered during a short sprint of only a few steps,with the accelerometer being held in a pocket. In some respects, thisdata has a similar shape to the shaking data of FIG. 21A. However, thex-axis appears to have more regular motion and distinctive peaks. Thus,if a user is instructed to shake an inhaler while orienting the inhalerin a particular way, this type of axis selection can be used to identifysignature motions. But this may not be necessary based on this data,because the magnitude of the x-axis peaks (approximately 3 gs peak totrough) is less than that of the signature motion (often closer to 3.5gs peak to trough) illustrated in FIG. 21A and FIG. 21B. Moreover, thefrequency of the data is different, with the running oscillation havingabout half the frequency of the prescribed shaking oscillation. Thisseems to be consistent because it typically takes longer for a runner'slegs to stride forward between steps that strike the ground than it doesfor a user's arm to shake rapidly back and forth in the air.

FIG. 21D shows data gathered during a short sprint of only a few steps,with the accelerometer being held in a hand. This data has an evenlarger movement, possibly even enough to rule it out as too large to bea prescribed shaking motion. This movement appears to have exceeded theaccelerometer's maximum abilities, since the data is clipped at the topand bottom extremes. Also the frequency is lower than the prescribedshaking shown in FIG. 21A, for example. This data in FIG. 21D appears tobe the closest to the prescribed shaking of FIG. 21A; the fact that eventhis data can be distinguished validates the hypothesis that anaccelerometer of this type may be sufficient for the monitoring andverifying as described herein.

FIG. 21E shows acceleration data for walking while holding theaccelerometer in a pocket. Both magnitude and frequency of the motionappears to be less than for the prescribed shaking motion of FIG. 21A.

FIG. 21F shows data for tossing the accelerometer into the air andcatching it repeatedly. The patterns shown in this data are quitedistinct from FIG. 21A. The frequency (e.g., distance as measured in thex-axis dimension from peak to peak) is much lower, for example.

The following table shows some of the numerical values for data from thetests and examples described above:

Positive Magnitudes Event Duration Crests or (gravities or gs) FrequencyEvent Type Number (sec) Peaks Troughs min-max (Hz) Shaking: 1 2 9 10  1-1.9 4.5 2 2.6 9 9 1.6-2 3.46 3 2 10 10 1.3-2 5 4 2 7 6 1.9-2 3.5 5 312 13 1.8-2 4 6 2 7 6 1.8-2 3.5 7 2.5 15 14 0.6-2 6 8 2 12 14 0.8-2 6 92 13 12   0.8-1.9 6.5 10 0.8 4 4   1.3-1.7 5 Running 1 3.5 9 8  −0.2-0.92.57 (pocket): 2 3.5 9 10   0.3-0.9 2.57 Running 1 4 10 9   0.9-1.9 2.5(hand): 2 4 10 9 1.7-2 2.5 Bike Ride 1 5 5 4   0.1-0.2 1 (pocket):

As indicated by the above data, the prescribed shaking motions have ahigher frequency (3.5-6.5) than the other motions (1-2.57). Prescribedshaking motions also have a high magnitude, but this is not quite asunique as frequency. This data tends to validate the hypothesis asdescribed above.

A detection algorithm can use the above findings. For example, a signalcan be analyzed or processed to identify feature such as those shown inFIG. 21A, including both the shape of a single shaking event and thepresence of multiple such events. Based on this data, frequency isperhaps more valuable than magnitude for identifying signature motions.

Detection of Disk Inhaler Use

A criterion for verifying that a disk inhaler has been used, forexample, is for the user to bring it to his or her mouth. Experimentswere performed to discover if these motions are indeed measurablydistinct. It was assumed that the data from picking up and putting downthe accelerometer would not be distinct—instead, the motion of bringingthe inhaler laterally toward and away from the mouth was a focus of theexperiments.

FIGS. 22A and 22B include data from picking up a DPI and moving itlaterally toward the mouth of a user. These data show a distinctpattern. Acceleration in gravities (gs) is plotted versus time. The datafor the accelerometer's x-axis is a bit noisy until the user begins totake the medication at approximately 600 in time in FIG. 22A, and atapproximately 950 in time in FIG. 22B.

FIG. 22C shows a user bringing the device up to their mouth and movingit away multiple times. The pattern that was detected above in FIG. 22Aand FIG. 22B is still evident in this data capture. After passing thisdata through a simple low pass filter the noise can be filtered out andthe pattern more easily detectable.

FIG. 22D shows data recorded during a longer process: that is, havingthe inhaler laying down, picking it up, moving it towards the mouth,breathing, moving it away and then putting it down. Once again thepattern is recognizable and can be detected even with the noise in thesystem. Accordingly, the approach appears to be validated by this data.

A detection algorithm can use the above findings. For example, a signalcan be analyzed or processed to identify features (e.g., signaturemovements) such as those shown in FIG. 22A-D. The magnitude may varywith the respect to the speed the user brings the device to their mouthbut an absolute magnitude can be determined, which may improve accuracy.The duration of the crest (corresponding to the duration the user isinhaling) can also be determined to filter out false positives. If theperiod is too short or too long then the data can be discarded. Thismotion may not be sufficient to verify that the user has taken theirmedication so data from other sensors in conjunction with this one maybe helpful to register it as a confirmed dispensing of a dose.

With respect to FIG. 23, FIG. 4F-FIG. 4I above show an example ofmonitor for a DPI inhaler that can include a rotating cover for theinhaler. The cover can be rotated to open it and grant a user access tothe mouthpiece to administer a medication dose. One or more rotation (orgyroscopic) sensors can be employed to detect this rotating motion. FIG.23 shows validation data from a gyroscopic sensor in this context. Somegyroscopic sensors have multiple sensors, aligned with orthogonal (orotherwise non-aligned) physical axes. In this example, data from threeorthogonal gyroscopic sensors is provided. The strong periodic patternvisible in the data from one sensor is not only distinctive (andtherefore a good candidate for a signature motion that can be used toverify inhaler deployment), it is also distinct from the data from theother sensor(s). Thus, multiple sensors and/or multiple orientations forindependent sensors can be used to avoid false positives and providemore reliable data.

Temperature Sensor Verification of Inhaler Use—Mouth Temperature

As noted above, directional temperature detectors can be used to verifyuse of an inhaler because a human's internal (e.g., mouth) temperatureis relatively high and relatively consistent. Measuring the temperatureof a skin surface such as a cheek can also be useful for verificationpurposes, although in some cases an internal temperature is moreconstant, particularly in warm-blooded mammals. The figures describedbelow show temperature on the vertical axis and time on the horizontalaxis. In each case, the data in the upper graph (FIG. 24A, FIG. 24C,FIG. 24E, etc.) is raw and the data in the lower graph (FIG. 24B, FIG.24D, FIG. 24F, etc.) results from applying a filter (e.g., a low-passfilter) to the raw data. For example, the low-pass filter can be afrequency-domain filter that helps smooth frequency jitter or othernoise effects in the data. The low-pass filter in some cases may beapplied in other domains such as the time domain. The data was collectedusing a CC2541 SensorTag device from Texas Instruments.

FIGS. 24A-24B show the difference between a temperature reading from adirectional temperature sensor aimed first into an air-conditioned room(ambient), then aimed at the surface skin on a human cheek (data featureroughly centered on 100), then back into ambient air. This same sequencewas repeated, as can be seen in the data of the two figures. The facetemperature is clearly warmer than the ambient temperature, and theresponse of the temperature sensor appears to be relatively rapid anddistinct. This data appears to validate that such a sensor can be usedfor the goals discussed herein—e.g., to help a monitor system determinewhen an inhaler has been positioned near or aimed toward a cheek of auser, and to track the length of time that position and/or orientationhas been maintained.

FIGS. 24C-24D show temperature data from four human exhale-inhale events(with FIG. 24C showing the raw data and FIG. 24D showing the data aftera low-pass filter has been applied). As can be seen, the temperaturechange is extreme, and easy to detect. Incidentally, the device seems tobe strongly affected by the condensation and evaporation of water frombreathing. This can be helpful because a very clear indication of humanbreath can make the monitoring or verification functions more robust. Onthe other hand, some sensors may be sensitive to water vapor and theenvironment may cause them to degrade more rapidly. Accordingly, it canbe helpful to encase or otherwise protect temperature sensors to allowthem to last a longer time, despite being subject periodically to warmand humid conditions associated with proximity to human breathing.

Because some embodiments may include a waterproof container or cover fora temperature sensor, FIG. 24E and FIG. 24F show data that was takenusing the clear plastic cover provided with the SensorTag. Like FIG. 24Cand FIG. 24D, these also show four human exhale-inhale events. Thetemperature change doesn't seem to be nearly as significant in the laterbreaths. Potentially this is because the cover stored and retained heatenergy from the earlier breaths, so that it was unable to cool asrapidly as the temperature sensor alone. Other covers having less massor having different heat retention and heat conductivity could be usedto mitigate or eliminate this effect.

FIG. 24G and FIG. 24H show data taken with a piece of plastic over thesensor to roughly simulate how it would work in a water-tight container.This data shows distinct breathing events, but with lower magnitude andless distinct profiles than those signatures depicted in FIG. 24A andFIG. 24B. However, the events are nevertheless distinguishable based onthe data provided here, further validating the approach describedherein. Different angles seem to affect the effectiveness of the sensoras well, as is expected from temperature sensors for which a sensitivedirectional axis is indicated.

FIG. 24I and FIG. 24J show data from further testing, which indicatevery distinct temperature changes. For this data, the sensor waspositioned at various distances from the target. In particular, thesensor was brought progressively closer to the mouth, followed byseveral breaths performed in front of the sensor. Between breaths thesensor is away from the face. The sensor has a wide field of view andaverages the temperatures over its entire field of view for the finalvalue, so the closer the sensor is to what it is measuring the more thattarget's temperature affects the overall sensor output. The relevantdistances from the target—e.g., on or associated with an inhalerhousing, given standard inhaler sizes—appear to provide satisfactoryresults. As indicated in these figures, there is a significant rise andfall in temperature when an exhale-inhale event occurs. This furthervalidates the use of a sensor for the methods described herein.

From the series of data shown above in FIG. 24A to FIG. 24J, it appearsthat using an infrared temperature gauge to detect the use of an inhalerby pointing it into the mouth is validated. Because the act of inhalingand exhaling, something necessary for the process of using an inhaler,creates a fairly distinctive change in the temperature reading of thesensor it is possible to use an algorithm to detect the act. Thetemperature of the mouth varies much less than that of the skin, basedon external factors, and the temperature of the mouth is higher thanthat of the skin in general, providing for a more distinctive value todetect. The fact that there is usually a drop after the breath also aidsin the detection of the breath.

Even if further data indicates smaller temperature differences between ahuman mouth and ambient air present on a very hot day or in a hot car,other facts can be considered. For example, an ambient air on a hot dayor in a hot car is typically not as humid as the air in or exhaled froma human mouth. Thus, further sensors could be used to determinehumidity, for example. Other sensors that measure optical effects suchas mouth color or reflectivity of moist pink surfaces, etc. can also beused in place of or in addition to temperature and/or humidity sensors.If a sensor is capable of evaluating absolute temperature or absolutehumidity (rather than simply relative temperature or relative humidity),that sensor, along with associated logic or a processor memory, can alsoevaluate whether its own data is reliable. For example, if a sensor andsystem are aware that ambient temperature and/or humidity are similar tothat of a human mouth, they may alert a user of this factor, annotatethe data to show how it should be evaluated, etc. Moreover, anydifficulty in measuring temperature is mitigated by the fact thattemperature is, in many of the systems described herein, filling therole of a secondary validation or confirmation of inhaler use, ratherthan as a primary indicator.

Temperature Sensor Verification of Inhaler Use—Pressurized Container

As noted above, the change in pressure involved as some pressurizedinhaler containers are discharged can also lead to temperature changesthat can be tracked or sensed with temperature sensors. MDI inhalersinclude pressurized cartridges that a patient actuates by pressing downand breathing in while the medication is sprayed out of a nozzle. Duringdispensing, the pressure of the contents decreases as it enters theatmosphere. Due to Gay-Lussac's law (P₁/T₁=P₂/T₂), the temperature ofthe canister also drops when the pressure decreases, causing anoticeable drop in temperature of the cartridge for each actuation ofthe MDI relative to the atmosphere.

Based on this physical theory, data was taken to validate how atemperature sensor could be used to measure this phenomenon in order toconfirm inhaler use and/or dispensation of medication from a pressurizedcontainer. Initial testing was inconclusive, but identified severalvariables to adjust and/or improve sensor and system design. Atemperature sensor can be positioned where a user's finger pushes on acanister to cause emission of medication. Thus, assuming a user's fingeris different from the ambient temperature and a glove is not being worn,etc., this can be an alternative manner of confirming inhaler use thatdoes not rely on the pressure and temperature effect described above.Temperature sensors that are not too sensitive to shaking are preferred,because inhaler shaking is prescribed and expected shortly beforedischarge of medication. Placement of a temperature sensor such that itcontacts the wall of a medication container without too muchinterference from an insulating sticker, for example, is preferred.Metal medication canisters are common, but a sensor may advantageouslyemploy an intermediary material that assists it in adhering to the edgeof the canister and also transfers heat appropriately. Heat emissivityof the medication container and/or any intermediary materials can bedesigned or accounted for.

Scope of Disclosure

Although this disclosure is made with reference to preferred and exampleembodiments, the systems and methods disclosed are not limited to thepreferred embodiments only. Rather, a person of ordinary skill willrecognize from the disclosure herein a wide number of alternatives.Unless indicated otherwise, it may be assumed that the process stepsdescribed herein are implemented within one or more modules, includinglogic embodied in hardware or firmware, or a collection of softwareinstructions, possibly having entry and exit points, written in aprogramming language, such as, for example C++. A software module may becompiled and linked into an executable program, installed in a dynamiclink library, or may be written in an interpretive language such asBASIC. It will be appreciated that software modules may be callable fromother modules or from themselves, and/or may be invoked in response todetected events or interrupts. Software instructions may be embedded infirmware, such as an EPROM or EEPROM. It will be further appreciatedthat hardware modules may be comprised of connected logic units, such asgates and flip-flops, and/or may be comprised of programmable units,such as programmable gate arrays or processors. The modules describedherein are preferably implemented as software modules, but may berepresented in hardware or firmware. The software modules may beexecuted by one or more general purpose computers. The software modulesmay be stored on or within any suitable computer-readable medium. Thedata described herein may be stored in one or more suitable mediums,including but not limited to a computer-readable medium. The datadescribed herein may be stored in one or more suitable formats,including but not limited to a data file, a database, an expert system,or the like.

The various illustrative logical blocks, modules, and processesdescribed herein may be implemented as electronic hardware, computersoftware, or combinations of both. To clearly illustrate thisinterchangeability of hardware and software, various illustrativecomponents, blocks, modules, and states have been described abovegenerally in terms of their functionality. However, while the variousmodules are illustrated separately, they may share some or all of thesame underlying logic or code. Certain of the logical blocks, modules,and processes described herein may instead be implementedmonolithically.

The various illustrative logical blocks, modules, and processesdescribed herein may be implemented or performed by a machine, such as acomputer, a processor, a digital signal processor (DSP), an applicationspecific integrated circuit (ASIC), a field programmable gate array(FPGA) or other programmable logic device, discrete gate or transistorlogic, discrete hardware components, or any combination thereof designedto perform the functions described herein. A processor may be amicroprocessor, a controller, microcontroller, state machine,combinations of the same, or the like. A processor may also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors orprocessor cores, one or more graphics or stream processors, one or moremicroprocessors in conjunction with a DSP, or any other suchconfiguration.

The blocks or states of the processes described herein may be embodieddirectly in hardware, in a software module executed by a processor, orin a combination of the two. For example, each of the processesdescribed above may also be embodied in, and fully automated by,software modules executed by one or more machines such as computers orcomputer processors. A module may reside in a computer-readable storagemedium such as RAM memory, flash memory, ROM memory, EPROM memory,EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, memorycapable of storing firmware, or any other form of computer-readablestorage medium known in the art. An exemplary computer-readable storagemedium can be coupled to a processor such that the processor can readinformation from, and write information to, the computer-readablestorage medium. In the alternative, the computer-readable storage mediummay be integral to the processor. The processor and thecomputer-readable storage medium may reside in an ASIC.

Each computing device may be implemented using one or more physicalcomputers, processors, embedded devices, field programmable gate arrays(FPGAs) or computer systems or a combination or portions thereof. Theinstructions executed by the computing device may also be read in from acomputer-readable medium. The computer-readable medium may be a CD, DVD,optical or magnetic disk, flash memory, laserdisc, carrier wave, or anyother medium that is readable by the computing device. In someembodiments, hardwired circuitry may be used in place of or incombination with software instructions executed by the processor.Communication among modules, systems, devices, and elements may be overa direct or switched connections, and wired or wireless networks orconnections, via directly connected wires, or any other appropriatecommunication mechanism. Transmission of information may be performed onthe hardware layer using any appropriate system, device, or protocol,including those related to or utilizing Firewire, PCI, PCI express,CardBus, USB, CAN, SCSI, IDA, RS232, RS422, RS485, 802.11, etc. Thecommunication among modules, systems, devices, and elements may includehandshaking, notifications, coordination, encapsulation, encryption,headers, such as routing or error detecting headers, or any otherappropriate communication protocol or attribute. Communication may alsomessages related to HTTP, HTTPS, FTP, TCP, IP, ebMS OASIS/ebXML, DICOM,DICOS, secure sockets, VPN, encrypted or unencrypted pipes, MIME, SMTP,MIME Multipart/Related Content-type, SQL, etc.

Depending on the embodiment, certain acts, events, or functions of anyof the processes or algorithms described herein can be performed in adifferent sequence, may be added, merged, or left out altogether. Thus,in certain embodiments, not all described acts or events are necessaryfor the practice of the processes. Moreover, in certain embodiments,acts or events may be performed concurrently, e.g., throughmulti-threaded processing, interrupt processing, or via multipleprocessors or processor cores, rather than sequentially.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments may or may not include, certain features, elements,benefits, capabilities and/or states. Thus, such conditional language isnot generally intended to imply that features, elements and/or statesare in any way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and/orstates are included or are to be performed in any particular embodiment.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the logical blocks, modules, and processesillustrated may be made without departing from the spirit of thedisclosure. As will be recognized, certain aspects of the disclosuredescribed herein may be embodied within a form that does not provide allof the features and benefits set forth herein, as some features may beused or practiced separately from others.

What is claimed is:
 1. A monitor system for detecting usage of aninhaler, the monitor system comprising: a compact housing configured tobe removably connectable to an inhaler that is configured to enclose anddeliver inhalable medication to a user; a controller located within thehousing; an inhaler communication interface within the compact housingin electronic communication with the controller and configured to sendand receive data; a memory and a battery in electrical communicationwith the controller and contained within the housing; a motion sensor inelectrical communication with the controller that outputs dataindicative of a motion of the housing, the motion sensor configured tobe physically coupled to the inhaler such that it can detect signaturemotions of the inhaler and the enclosed medication, the signaturemotions comprising at least two movements of the inhaler occurringwithin a first time window of one another and indicative of preparationby a user for administration of a dose of the medication; a temperaturesensor in electrical communication with the controller, the temperaturesensor configured to detect confirming temperatures on or near theinhaler within a second time window of any signature motions, thetemperature sensor configured to be within a given distance of the mouthof the user, the temperatures indicative of a proper dosage breathingpattern, the temperatures indicative that a dose of the medication wasadministered; a mobile personal computing device remote from the housingand configured to receive data from the inhaler communication interface,the computing device having a processor configured to: process dataoutput from the motion sensor to identify signature motions bycomparison to reference data from a database, the reference dataindicating sensor results indicative of preparation by a user and properadministration of a dose of the medication; process data output from thetemperature sensor to identify confirming temperatures indicative ofproper administration of a dose of the medication; and evaluate timingof any signature motions in the first time window and confirmingtemperatures in the second time window to determine whether a use of theinhaler has occurred; and cause the mobile personal computing device todisplay information to the user related to compliance with themedication dosage regimen.
 2. The monitor of claim 1 wherein evaluatingthe timing includes determining whether the temperature data indicativeof use occurred later in time than the motion data indicative of use. 3.The monitor of claim 1 wherein the confirming temperatures comprise atemperature increase in proximity to a mouthpiece connected to thehousing of the inhaler.
 4. The monitor of claim 1 wherein the confirmingtemperatures comprise a temperature increase by an amount indicative ofa patient's mouth being in proximity to a mouthpiece connected to aninhaler housing.
 5. The monitor of claim 1 wherein the controller isconfigured to process data output from the motion sensor to identifysignature motions that result from a lever being actuated on a DPIinhaler.
 6. A method of using a disposable sensor package incommunication with a mobile personal computing device, the methodcomprising: attaching a disposable package comprising one or moresensors to an inhaler; using at least one sensor in the disposablepackage to detect data relating to signature motions that comprise atleast two movements of the inhaler and indicative of preparation by auser and administration of a dose of the medication; using at least onesensor in the disposable package to detect one or more temperaturesusing a sensor outside and near the mouth of the user within a timewindow of any signature motions, the temperatures indicative of a dosagebreathing pattern for medication dosage; using an inhaler communicationinterface within the disposable package to transmit the motion andtemperature data to a mobile personal computing device of the user;using the mobile personal computing device to process the motion data todetermine whether it includes one or more signature motions indicativeof proper preparation and use of the inhaler; using the mobile personalcomputing device to process the temperature data to determine whether itis indicative of proper dosage breathing patterns for effectivemedication dosage; and using the mobile personal computing device toevaluate the timing of the signature motion data relative to thetemperature data to determine whether the inhaler has been properlyused.
 7. The method of claim 6, further comprising associating a date,time, and location with a use after the evaluating step has confirmedthat a proper use of an inhaler has occurred.
 8. The method of claim 6,wherein the disposable package includes a temperature sensor configuredto measure the temperature of a medication container and the processingof the temperature data includes determining whether a temperature ofthe inhaler container has changed.
 9. The method of claim 6, whereinusing the mobile personal computing device to process the motion dataincludes determining whether a frequency of the acceleration reaches athreshold magnitude and the duration of acceleration above thethreshold.
 10. A universal monitor system for detecting and assessingusage of an inhaler, the monitor system comprising: a compact housingconfigured to be removably connectable to an inhaler; a controller; aninhaler communication interface in electronic communication with thecontroller; at least two sensors in the compact housing and configuredto be physically present during inhaler use, the sensors including atleast two of the following: a motion sensor; an accelerometer; atemperature sensor; a proximity sensor; an infrared sensor; an audiosensor; and a vibration sensor; a mobile personal computing deviceremote from the compact housing and configured to receive data from theinhaler communication interface, the computing device having a processorconfigured to: process data output from the at least two sensors toidentify at least two relevant sensor readings; process data output fromthe at least two sensors to assess if the sensor readings are signaturereadings, indicating proper administration of a dose of the asthmamedication; and evaluate timing of any signature readings to determineor confirm whether a proper use of the asthma inhaler has occurred; anda user display configured to receive output from the processor andindicate whether or not proper usage and compliance with the medicationdosage regimen has occurred.
 11. The universal monitor system of claim10, wherein: the compact housing is configured for connection to atleast two of the following inhaler types: metered dose inhaler, drypowder inhaler, disk inhaler, and nebulizer; the at least two sensorsare selected to provide data relevant to assess proper medication dosagefrom at least the two inhaler types; and the processor is configured toassess signature readings for the at least two inhaler types so that theuniversal monitor can be used on either type and is not specific to onlyone type of inhaler.
 12. The universal monitor of claim 11 wherein theat least two sensors comprise perpendicular accelerometers.
 13. Theaccelerometer of claim 12 wherein the accelerometers monitor motion datafor acceleration with respect to at least one reference acceleration ineach of two perpendicular dimensions.
 14. The universal monitor of claim11 wherein the at least two sensors comprise a gyroscope that monitorsorientation.
 15. The universal monitor of claim 12 wherein the at leasttwo sensors comprise a temperature sensor that monitors changes intemperature in proximity of the inhaler related to medicationdispensation or mouth proximity.
 16. The universal monitor of claim 12wherein the at least two sensors comprises an infrared proximity sensorthat monitors proximity of the inhaler to the user's face.
 17. Theuniversal monitor of claim 12 wherein the at least two sensors comprisean audio sensor that monitors sounds generated by the user and inhalerduring use of the device.
 18. The universal monitor of claim 12 whereinthe at least two sensors comprise a vibration sensor that monitors for adistinct vibration associated with use of the inhaler.
 19. The universalmonitor of claim 11 wherein the at least two sensors comprise multipletemperature sensors, including an ambient temperature sensor thatmonitors ambient temperature to provide a reference temperature.
 20. Theuniversal monitor of claim 11 wherein the processor is configured tosend a notification to the user that the cartridge is at a certaincapacity, to request the user to order a refill cartridge, to receive acommand from the user to order the refill cartridges, to connect to anetwork, or to directly order the refill cartridges.